FDA Device recall Z-0555-2016
Merge Cardio with software version 10.1 LA
- FDA Device
- Class II
- terminated
- Published 2016-01-06
On 2016-01-06 the FDA classified a Class II recall of Merge Cardio with software version 10.1 LA by Merge Healthcare, citing the firm, Merge Healthcare, sent out Merge HEMO V10.0 & Merge CARDIO V10.1 software to 3 customers before the product was completely validated in house.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0555-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-10-26 |
| Published | 2016-01-06 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Merge Healthcare |
| Distribution | IL, NC, VT |
Product
Merge Cardio with software version 10.1 LA.
Reason
The firm, Merge Healthcare, sent out Merge HEMO V10.0 & Merge CARDIO V10.1 software to 3 customers before the product was completely validated in house.
Identifiers
| code_info | Merge Cardio with software version 10.1 LA. Merge Cardio is intended to allow users to review diagnostic and non-diagnostic quality images. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0555-2016%22
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