Reported Aug 5, 2015 · Terminated
Invivo Expression MRI Patient Monitoring System.
Philips Electronics North America Corporation
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 Electronics North America Corporation · 3000 Minuteman Rd · Andover, MA · 01810-1032
Is this the product you have?
- Invivo Expression MRI Patient Monitoring System.
- Lot codes and dates
- Model Number 865214 (Invivo Expression MRI Patient Monitoring System) Devices with the FlexTEMP reusable temperature option installed (serial number range US31204918 through US42708744). Please note that not every serial number within the listed range has the temperature option. Devices without the temperature option are not affected by this Medical Device Correction
- Serial Numbers
653 of 653 codes
US31204918US31204919US31204920US31204924US31204925US31204926US31204927US31204928US31204929US31204930US31204931US31204933US31204935US31204943US31204944US31204945US31204946US31204950US31204951US31204952US31204956US31204959US31204960US31204962US31204963US31204964US31204965US31204966US31204967US31204970US31204971US31204972US31205010US31205029US31205030US31205037US31205038US31205054US31205074US31205075US31205076US31205078US31205081US31205082US31205083US31205089US31205090US31205091US31205092US31205106US31205107US31205108US31205109US31205141US31205142US31205143US31205148US31205180US31205208US31205209
- Amount recalled
- 697 devices.
Where it was sold
Why it was recalled
The device's labeling inaccurately indicates Endotracheal as a body temperature application site. The FlexTEMP reusable temperature sensor is not intended to be used for endotracheal placement. The application site should be listed as Esophageal.
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 Electronics North America Corporation 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.