Medfusion 4000 software versions referenced in FDA and manufacturer notices run from v1.0.0 to v1.6.5, plus v1.7.0, which was recalled in 2019. The most recent Class I recall, initiated in December 2023 (FDA recall number Z-0864-2024), covers legacy software issues that are fixed in later releases, and Smiths Medical (part of ICU Medical since 2022) directs users to install the most recent software, v1.6.5, specifically telling biomed teams to update pumps running v1.5.0 through v1.6.4. Check the version on your pump’s start-up screen, confirm it against the notices below, and make sure your annual PM includes the updated force sensor check. ICU Medical has also told users not to use Cardinal Health-branded Monoject syringes on Medfusion 3500 and 4000 pumps.
The Medfusion 4000 has been the subject of several FDA-tracked recalls and field corrections since its introduction. Many involve software and are resolved by a software update; others involve hardware such as the barrel clamp, force sensor and AC power receptacle. This guide puts them in one place, in plain English, so your team can tell which pumps are affected and what to do next.
Medfusion 4000 Software Versions
Every Medfusion 4000 looks the same from the outside. The software version determines which features the pump has and which corrections apply. Here are the version families referenced in ICU Medical and FDA documents:
| Version | Status | Notes |
|---|---|---|
| v1.0.0 and v1.1.x (1.1.0–1.1.2) | Legacy | Original release family. Covered by the 2012 recall and by issues listed in the 2022 and 2023 recalls. |
| v1.5.0 and v1.5.1 | Update to v1.6.5 | v1.5.0 was released in 2014 and fixed the earliest legacy issues. |
| v1.6.0 and v1.6.1 | Update to v1.6.5 | Covered by the 2020, 2022 and 2023 recalls. |
| v1.6.4 | Update to v1.6.5 | Released in 2022. |
| v1.7.0 | Recalled | Subject of the 2019 Class I recall; affected pumps were to be returned to the manufacturer. |
| v1.6.5 | Current remediation | Released in 2023. Fixes the Depleted Battery alarm duration and loss-of-Wi-Fi issues in the December 2023 recall. |
Not sure what a version means for your fleet? Contact us with the version on the start-up screen and we will help you sort it out.
How to Check Your Medfusion 4000 Software Version
- Turn the pump on and watch the start-up screen during the self-test.
- Note the software version shown (for example, V1.6.5).
- Compare it with the table above and with the Operator’s Manual edition you use; the manual says the two should always match.
- Record the version for each pump in your asset system so you can act quickly on future notices.
Medfusion 4000 Class I Recalls
Class I is FDA’s most serious recall classification. Five Class I recalls have involved the Medfusion 4000:
| Initiated | FDA recall number | Versions | Issue | Remedy |
|---|---|---|---|---|
| February 2012 | Z-2107-2012 | v1.0 and v1.1 | Corruption of the device history log could trigger a “Watchdog Fail-Safe” alarm and stop the pump. | Software upgrade by the manufacturer. |
| October 2019 | Z-0610-2020 | v1.7.0 | Loss of the primary audible and visual battery alarm, which could interrupt therapy. | Affected pumps returned to the manufacturer. |
| June 2020 | Z-2734-2020 | v1.5.0–v1.6.1 (the manufacturer’s updated notice adds v1.7.0) | Over- or under-delivery if an interrupted bolus or loading dose is resumed after priming. | Do not resume an interrupted bolus or loading dose after priming; start a new infusion instead. |
| April 2022 | Z-1271-2022 | Varies by issue; several affect versions through v1.6.1 | Eight issues on the 3500 and 4000 (seven software, one circuit-board), including false primary audible alarm failures, unexpected Depleted Battery alarms under heavy wireless traffic, false “Rate Below Recommended Minimum” alarms and PharmGuard Server communication problems. | Software updates for pumps within their service life; pumps in a specific serial number range returned for repair. |
| December 2023 | Z-0864-2024 | Pump software v1.0.0 through v1.6.4 (all versions before v1.6.5 for the Depleted Battery issue), plus PharmGuard Server v2.3–v2.5 | Ten legacy issues (nine pump software, one PharmGuard Server), each fixed in a later release (pump v1.5.0, v1.6.4 or v1.6.5; Server v2.6). | Install the most recent software (v1.6.5). The notice specifically directs updating pumps on v1.5.0–v1.6.4 to v1.6.5, and PharmGuard Server v2.3–v2.5 to v2.6. |
The December 2023 notice is the one most fleets need to act on today, because two of its issues, a Depleted Battery alarm that may not sound for its full three minutes and loss of wireless connectivity to PharmGuard Server, are fixed only in v1.6.5. If your pumps run anything earlier, plan the update.
Hardware and Syringe Corrections
Several Class II corrections affect the pump’s hardware rather than its software. These are the ones most relevant to biomed teams:
| Initiated | FDA recall number | Issue |
|---|---|---|
| November 2013 | Z-0540-2014 | Electrical shorting at the AC power receptacle when saline or other conductive fluid gets in. |
| August 2017 | Z-0313-2018 | The barrel clamp mechanism could loosen, causing “Invalid Syringe Size” alarms. |
| November 2017 | Z-1134-2018 | The pump might not recognize, or might misidentify, the loaded syringe (Medfusion 3500, 4000 and other series). |
| April 2018 | Z-2662-2018 | A ridge on the barrel clamp guide let its spring slip, causing syringe recognition errors. |
| December 2015 (classified 2022) | Z-0653-2022 | Supercap POST and Backup Audible Alarm errors at start-up on pumps and replacement main boards built April 2012 to June 2015; a 2022 follow-up said no repair is required. |
| October 2018 | Z-2554-2019 | Duplicate wireless MAC addresses on some pumps used with PharmGuard Server. |
| October 2022 | Z-0272-2023 | Possible delay in sending Infusion Start messages to EHR systems on v1.6.0 and v1.6.1 pumps using Smart Pump Programming. |
| August 2023 | Z-0079-2024 | The occlusion force sensor can drift out of calibration, slowing occlusion detection or causing false occlusion alarms (3500 and 4000). A new check was added to the annual force sensor test. |
| December 2023 | Z-1541-2024 | A molding defect in certain lots of the barrel clamp guide could cause syringe recognition errors on pumps built or serviced with those parts. |
Most of these show up at the bedside as syringe recognition alarms or occlusion alarms. Our Medfusion 4000 common problems guide covers what we find when those pumps reach our lab.
Cardinal Health Monoject Syringe Warning
In February 2024, Smiths Medical (now part of ICU Medical) issued an urgent correction telling users not to use Cardinal Health-branded Monoject syringes on Medfusion 3500 and 4000 pumps. FDA issued a related letter to health care providers. Covidien-branded Monoject syringes were not part of that warning. Both brands print only “monoject” on the syringe itself, so ICU Medical advises keeping Covidien syringes in their outer packaging until use. Check your syringe stock and your pump configurations, and follow ICU Medical’s current guidance for your facility.
What to Do Now: A Checklist for Biomed and HTM Teams
- Record the software version of every Medfusion 4000 in your fleet.
- Plan updates to v1.6.5 for any pump below that version, and contact ICU Medical about the update path for pumps on v1.0 or v1.1.
- Make sure clinicians know not to resume an interrupted bolus or loading dose after priming.
- Run the annual force sensor check using the latest Technical Service Manual procedure, including the added check from the 2023 correction.
- Inspect barrel clamps and watch for repeat “Invalid Syringe Size” or syringe recognition alarms.
- Remove Cardinal Health-branded Monoject syringes from Medfusion pump areas.
- Check ICU Medical’s customer communications page and FDA’s recall database for anything newer than this guide.
How IPR Medical Can Help
Version guidance
We can check your pumps’ software versions against the published notices.
Software updates in-house
We update pump software as part of service at our ISO 9001:2015-certified facility in Tustin, California.
Force sensor and syringe sensing repairs
We calibrate and test occlusion detection and repair barrel clamps, plunger assemblies and syringe sensors.
Free evaluation and shipping label
U.S. customers get a free inbound label and a free evaluation. Request a free label.
Need pumps instead? Shop recertified (refurbished) Medfusion 4000 wireless syringe pumps, compare models in our Medfusion 3500 vs 4000 guide, or find manuals in our Medfusion 4000 manuals guide. For repairs, see our Medfusion repair service.
Medfusion 4000 Recall FAQ
Is the Medfusion 4000 recalled?
The Medfusion 4000 has been the subject of several FDA recalls and corrections. Many involve software and are resolved by a software update; others involve hardware. The most recent Class I recall, initiated in December 2023, covers legacy issues fixed in later releases. It was a correction, not a product removal.
What is the latest Medfusion 4000 software version?
The most recent version referenced in the manufacturer’s recall correspondence is v1.6.5, released in 2023. The December 2023 notice asks users to install the most recent software and specifically directs updating pumps on v1.5.0 through v1.6.4 to v1.6.5.
How do I check the software version on a Medfusion 4000?
Turn the pump on. The software version appears on the start-up screen during the self-test.
What was the Medfusion 4000 interrupted bolus recall?
In June 2020, a Class I recall (Z-2734-2020) warned that resuming an interrupted bolus or loading dose after priming could cause over- or under-delivery. The instruction was not to resume after priming and to start a new infusion instead.
Why does my Medfusion 4000 show “Invalid Syringe Size”?
Several corrections have involved syringe recognition, including barrel clamp loosening and barrel clamp guide defects. Make sure the syringe is seated correctly and is a supported model. If the alarm repeats, the pump should be evaluated.
Can I use Monoject syringes on a Medfusion 4000?
The manufacturer’s February 2024 correction says not to use Cardinal Health-branded Monoject syringes on Medfusion 3500 and 4000 pumps. Covidien-branded Monoject syringes may still be used, but both brands print only “monoject” on the syringe, so keep the outer packaging with the syringe until it is loaded. Follow the manufacturer’s current guidance.
Does IPR Medical update Medfusion 4000 software?
Yes. We update pump software as part of service. Contact us about your fleet.
Sources
- FDA recall database: Z-0864-2024 (December 2023, Class I)
- FDA notice: Medfusion Model 4000 legacy software recall
- FDA recall database: Z-1271-2022 (April 2022)
- ICU Medical letter: Medfusion software anomalies (April 2022)
- ICU Medical letter: Medfusion 4000 legacy software issues (FA2310-01)
- FDA recall database: Z-2734-2020 (interrupted bolus or loading dose)
- FDA recall database: Z-0610-2020 (v1.7.0)
- FDA recall database: Z-2107-2012 (v1.0 and v1.1)
- FDA recall database: Z-0079-2024 (force sensor)
- FDA letter to health care providers: Cardinal Health Monoject syringes
- ICU Medical: Medfusion customer communications and clinical bulletins
Not Sure Which of Your Pumps Are Affected?
Send us the software versions, or send the pumps in for a free evaluation. We will check them against the published notices and tell you what we can confirm; for notices tied to specific serial numbers or part lots, the manufacturer’s response form lists the affected units.
Medfusion, PharmGuard, Monoject, Cardinal Health and Covidien are trademarks of their respective owners and are used here only to identify the original manufacturer’s equipment and products. IPR Medical is an ISO 9001:2015-certified independent service organization and is not sponsored by, affiliated with, or endorsed by the original equipment manufacturer. All other product names and trademarks are the property of their respective owners and are used only to identify those owners’ products; IPR Medical is not sponsored by, affiliated with, or endorsed by any of these trademark owners. This guide summarizes public FDA and manufacturer information for convenience; it is not a substitute for the manufacturer’s notices. Always follow the most current instructions from the manufacturer and FDA.