Merge OfficePACS software. The firm name on the label is Merge Healthcare, Hartland, WI. OfficePACS is intended for the
FDA device recall Z-2144-2016 · posted 2016-07-08 · Terminated
Recall details
- Recalling firm
- Merge Healthcare, Inc.
- Reason for recall
- Potential data loss occurs as a result of the software archiving not working properly.
- Action taken
- Merge Healthcare sent an Urgent Medical Device Recall letter dated January 26, 2016, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customers. Customers were instructed to provide a copy of the notification to all users. For additional questions customers were advised to call Merge Customer Service at (87) 741-5369. For questions regarding this recall call 262-367-0700.
- Root cause
- Software design
- Status
- Terminated
- Product code
- LLZ
- Quantity affected
- 216 sites have the affected software
- Distribution
- The software was distributed nationwide to medical facilities. There was no government/military/foreign distribution.
- Date initiated
- 2016-01-30
- Date posted
- 2016-07-08
- Date terminated
- 2017-02-03
- Location
- Hartland, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ORTHOPACS (K033825) | Etrauma.Com Corp. | 2004-02-02 |