Angiographic Injector — Class II medical device recall Z-2775-2015
Terminated recall by Bayer Healthcare, reported 2015-09-23, distributed nationwide. Software Version SW 005.006_SH, resulted in the removal of purge enforcement from traditional New-Case, Power
| Recall number | Z-2775-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Bayer Healthcare, Indianola, PA, United States |
| Recall initiated | 2015-08-04 |
| Classified | 2015-09-16 |
| Reported by FDA | 2015-09-23 |
| Terminated | 2016-08-17 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, DE, FR, GB, NL, SE |
| Quantity | 71 |
| Reason classes | software |
| Serial numbers | 100002, 100009, 100013, 100033, 100056, 100075, 100092, 100141, 100186, 100249, 100335, 100511, 10055, 10074, 100784, 100864, 10087, 100873, 100890, 100945, 10095, 101106, 101114, 101148, 101149 and 46 more |
| Model numbers | 700 |
Product
Angiographic Injector. Medrad Mark 7 Arterion Injection System, which utilizes Software Version SW 005.006_SH; to be used specifically for the purposes of injecting contrast medium and common flushing solutions into humans for angiographic studies.
Reason for recall
Software Version SW 005.006_SH, resulted in the removal of purge enforcement from traditional New-Case, Power Up and Syringe Change use cases while the injector head is in the upright position.
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-2775-2015. 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.