Merge OfficePACS software. The firm name on the label is Merge Healthcare, Heartland, WI.
FDA device recall Z-2159-2016 · posted 2016-07-11 · Terminated
Recall details
- Recalling firm
- Merge Healthcare, Inc.
- Reason for recall
- Potential data loss occurs as a result of product archiving not working properly.
- Action taken
- The recalling firm issued a letter dated 1/27/2016 via e-mail on 1/31/2016 explaining the reason for recall and instructing the customer to provide a copy of the notification to all users.
- Root cause
- Software design
- Status
- Terminated
- Product code
- LLZ
- Quantity affected
- 49 sites have the affected software
- Distribution
- Distribution was made to medical facilities located in AL, AZ, CA, CO, CT, FL GA, ID, IL, KY, MA, MO, NE, NH, NJ, NY, NC, OK, PA, SC, TN, VA, and WA. There was no government/military/foreign distribut
- Date initiated
- 2016-01-31
- Date posted
- 2016-07-11
- Date terminated
- 2017-01-26
- Location
- Hartland, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ORTHOPACS (K033825) | Etrauma.Com Corp. | 2004-02-02 |