FDA Device recall Z-2266-2015
Invivo Expression MRI Patient Monitoring System
- FDA Device
- Class II
- terminated
- Published 2015-08-05
On 2015-08-05 the FDA classified a Class II recall of Invivo Expression MRI Patient Monitoring System by Philips Electronics North America, citing 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 endotrach….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2266-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-06-17 |
| Published | 2015-08-05 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Philips Electronics North America |
| Distribution | US |
Product
Invivo Expression MRI Patient Monitoring System.
Reason
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.
Identifiers
| code_info | Model Number 865214 (Invivo Expression MRI Patient Monitoring System) Devices with the FlexTEMP reusable temperature op…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: US31204918, US31204919, US31204920, US31204924, US31204925, US31204926, US31204927, US31204928, US31204929, US31204930, US31204931, US31204933, US31204935, US31204943, US31204944, US31204945, US31204946, US31204950, US31204951, US31204952, US31204956, US31204959, US31204960, US31204962, US31204963, US31204964, US31204965, US31204966, US31204967, US31204970, US31204971, US31204972, US31205010, US31205029, US31205030, US31205037, US31205038, US31205054, US31205074, US31205075, US31205076, US31205078, US31205081, US31205082, US31205083, US31205089, US31205090, US31205091, US31205092, US31205106, US3120 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2266-2015%22
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