Invivo Expression MRI Patient Monitoring System — Class II medical device recall Z-2266-2015
Terminated recall by Philips Electronics North America Corporation, reported 2015-08-05, distributed nationwide. The device's labeling inaccurately indicates Endotracheal as a body temperature application site. The FlexTEMP
| Recall number | Z-2266-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips Electronics North America Corporation, Andover, MA, United States |
| Recall initiated | 2015-06-17 |
| Classified | 2015-07-27 |
| Reported by FDA | 2015-08-05 |
| Terminated | 2019-10-02 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, CA, CZ, DE, DK, EG, ES, FR, GB, HK, IL, IS, IT, JP, NL, NO, OM, PL, PT, SA, SE, SI, ZA |
| Quantity | 697 devices |
| Reason classes | labeling |
| 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 and 475 more |
| Model numbers | 865214 |
Product
Invivo Expression MRI Patient Monitoring System.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2266-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.