Reported Jun 2, 2021 · Terminated
IntelliVue MX40 Patient Monitor, Model Number: 865350 (US) 865352 (OUS) Software version number B.06.59 - Product…
Philips North America LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Philips North America Llc · 222 Jacobs St · Cambridge, MA · 02141-2289
Is this the product you have?
- IntelliVue MX40 Patient Monitor
- Model Number865350 (US) 865352 (OUS) Software version number B.06.59 -
- Product UsageIntended for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults and pediatrics in hospital environments and during transport inside hospitals
- Lot codes and dates
- Serial numbersUS09699788 (US)
- US156J6219 (US) US156J3658 (OUS) UDI(01)00884838082236 (21)US09699788 (01)00884838082236 (21)US156J6219 (01)00884838030350 (21)US156J3658
- Amount recalled
- 3 units
Where it was sold
Why it was recalled
Manufacturing failed to follow process steps resulting in the distribution of potentially defective devices
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Philips North America LLC recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.