Ingenia MR-OR; 781437, 781438 The MR-OR option is intended for allowing transfer of a neurosurgical patient from OR suit
FDA device recall Z-0825-2017 · posted 2016-12-19 · Terminated
Recall details
- Recalling firm
- Philips Electronics North America Corporation
- Reason for recall
- Possibility that a patient or user may be exposed to a very small level of touch current.
- Action taken
- Philips sent an Urgent Field Safety Notice Medical Device Correction letter dated November 2016 to all affected customers. The letter explains the issue and actions planned by Philips. There is no need for action to be taken by customer or user. Customers with questions should contact their local Philips representative Technical Support Line 1-800-722-9377.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- LNH
- Quantity affected
- 9
- Distribution
- Worldwide Distribution -US including CA, NY and Internationally to United Kingdom, Australia, Norway, and Thailand
- Date initiated
- 2016-12-01
- Date posted
- 2016-12-19
- Date terminated
- 2017-08-31
- Location
- Andover, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ACHIEVA R4 1.5T AND ACHIEVA R4 3.0T (K110151) | Philips Health Care | 2011-03-22 |