FDA Device recall Z-2244-2016
Angiographic Injector and Syringe, MEDRAD MRXperion MR Injection System, MEDRAD MRXperion Sterile Disposable MRI Kit Usage: The MEDRAD MRXp…
- FDA Device
- Class II
- terminated
- Published 2016-07-27
On 2016-07-27 the FDA classified a Class II recall of Angiographic Injector and Syringe, MEDRAD MRXperion MR Injection System, MEDRAD MRXperion Sterile Disposable MRI Kit Usage: The MEDRAD MRXp… by Bayer Healthcare, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2244-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-06-09 |
| Published | 2016-07-27 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Bayer Healthcare |
| Distribution | NY |
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
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.
Identifiers
| code_info | Catalog numbers: MRXP 200 Serial numbers: 100009, 100011, 100019, 100020, 100022, 100026, 100027, 100028, 100036, 1000…Catalog numbers: MRXP 200 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, 100104, 100106, 100107, 100108, 100109, 100110, 100111, 100112, 100113, 100114, 100118, 100119, 100129, 100152, 100155, 100161, 100166 |
|---|
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-2244-2016%22
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