Merge OfficePACS software — Class II medical device recall Z-2159-2016
Terminated recall by Merge Healthcare, Inc., reported 2016-07-20, distributed in AL, AZ, CA, CO, CT, FL, GA, ID…. Potential data loss occurs as a result of product archiving not working properly.
| Recall number | Z-2159-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Merge Healthcare, Inc., Hartland, WI, United States |
| Recall initiated | 2016-01-31 |
| Classified | 2016-07-11 |
| Reported by FDA | 2016-07-20 |
| Terminated | 2017-01-26 |
| Distributed | AL, AZ, CA, CO, CT, FL, GA, ID, IL, KY, MA, MO, NC, NE, NH, NJ, NY, OK, PA, SC, TN, VA, WA |
| Quantity | 49 sites |
Product
Merge OfficePACS software. The firm name on the label is Merge Healthcare, Heartland, WI.
Reason for recall
Potential data loss occurs as a result of product archiving not working properly.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2159-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.