Angiographic Injector and Syringe — Class II medical device recall Z-2244-2016
Terminated recall by Bayer Healthcare, reported 2016-07-27, distributed in NY. Bayer Healthcare is initiating this recall due to complaints that were received from customer sites describing
| Recall number | Z-2244-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Bayer Healthcare, Indianola, PA, United States |
| Recall initiated | 2016-06-09 |
| Classified | 2016-07-19 |
| Reported by FDA | 2016-07-27 |
| Terminated | 2016-12-05 |
| Distributed | NY |
| Quantity | 42 units |
| Serial numbers | 100009, 100011, 100019, 100020, 100022, 100026, 100027, 100028, 100036, 100047, 100065, 100066, 100069, 100074, 100075, 100085, 100090, 100091, 100096, 100097, 100098, 100099, 100100, 100101, 100103 and 17 more |
Product
Angiographic Injector and Syringe, MEDRAD MRXperion MR Injection System, MEDRAD MRXperion Sterile Disposable MRI Kit Usage: The MEDRAD MRXperion MR Injection System is a syringe based fluid delivery system indicated for delivery of contrast media and saline during MR applications. It is intended to be used for the specific purpose of injecting intravenous MR contrast media and saline into the human vascular system for diagnostic studies in magnetic resonance imaging (MRI) applications with MRI scanners that have a magnetic field strength between 0.7 and 3.0 Tesla. Only trained healthcare professionals are intended to operate this device.
Reason for recall
Bayer Healthcare is initiating this recall due to complaints that were received from customer sites describing a 4205 error message when the injector is used with a 3T scanner.
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-2244-2016. 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.