Recall Z-0399-2017 ยท JQP Calculator/Data Processing Module, For Clinical Use
Merge Healthcare, Inc.
Merge LIS software.
| Date | Mar 5, 2015 |
| Status | Terminated |
| Reason | There is a potential for duplicate container numbers to be created for patients. |
| Root cause | Software design |
| Action | The recalling firm issued a letter dated 1/27/2016 via e-mail on 1/30/2016. If no email address was available, the letters were issued via certified mail. Letters to nonresponders were issued 5/26/2016. |
| Quantity | 413 sites potentially have the affected software |
| Distribution | Distribution was made nationwide and to the Virgin Islands. Foreign distribution was made to the Bahamas. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.