Invivo Expression MRI Patient Monitoring System.
FDA device recall Z-2266-2015 · posted 2015-07-27 · Terminated
Recall details
- Recalling firm
- Philips Electronics North America Corporation
- 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.
- Action taken
- An URGENT Medical Device Correction was sent to all consignees by letter June 2015 regarding the Invivo Expression MRI Patient Monitoring System FlexTEMP Application Site explaining the reason for the affected labeling.
- Root cause
- Labeling False and Misleading
- Status
- Terminated
- Product code
- MWI
- Quantity affected
- 697 devices.
- Distribution
- Worldwide Distribution-US (nationwide) including the states of AL, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NV, NY, OH, OR, OK, PA, SC, TN, TX, U
- Date initiated
- 2015-06-17
- Date posted
- 2015-07-27
- Date terminated
- 2019-10-02
- Location
- Andover, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MRI PATIENT MONITORING SYSTEM (MODEL 865214) (K124061) | Invivo Corporation | 2013-02-22 |