Recall Z-2244-2016
Bayer Healthcare · initiated June 9, 2016
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: 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
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.
FDA-determined cause: Device Design
Action taken
Bayer sent an Urgent Medical Device Field Corrective Action letter dated June 8, 2016 to affected customers. The letter identified the affected product, problem and actions to be taken. The letter instructed customers to take the following steps should a 4205 error message is encountered. For questions contact Bayer Customer Support Team at 1-800-633-7237.
Details
- Recall number
- Z-2244-2016
- Initiated
- June 9, 2016
- Terminated
- December 5, 2016
- Product code
- DXT – Injector And Syringe, Angiographic
- Quantity
- 42 units
- Distribution
- Worldwide and the US state of NEW YORK
- Recalling firm
- Bayer Healthcare, Indianola, PA