The Well@Home Monitor by Patient Care technologies Model 179-2150 Intended to be used as a clinical tool for remotely mo
FDA device recall Z-2166-2010 · posted 2010-08-03 · Terminated
Recall details
- Recalling firm
- Zoe Medical Incorporated
- Reason for recall
- Touch panel may become unresponsive.
- Action taken
- Zoe Medical notified the 2 distributors by e-mail on January 26, 2009 and Feb 6, 2009 of the recall, requesting return of the units for correction.
- Root cause
- Component change control
- Status
- Terminated
- Product code
- DXN
- Quantity affected
- 62
- Distribution
- Nationwide Distribution -- MA and MD.
- Date initiated
- 2009-02-02
- Date posted
- 2010-08-03
- Date terminated
- 2010-08-03
- Location
- Topsfield, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| WELL@HOME SYSTEM (K040012) | Zoe Medical, Inc. | 2004-04-02 |