Bayer Recalls MEDRAD MRXperion MRI Injection Systems Due to Error Messages
Bayer Healthcare is recalling 42 MEDRAD MRXperion MR Injection Systems because they display a 4205 error message when used with 3T scanners.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text describes a functional error message without reporting any injuries, illnesses, or deaths, fitting the criteria for a moderate severity recall.
Plain-English summary
Bayer Healthcare is recalling 42 units of the MEDRAD MRXperion MR Injection System and MEDRAD MRXperion Sterile Disposable MRI Kit. The recall was initiated due to customer complaints that the injector displays a 4205 error message when used with a 3T scanner. The affected devices are identified by catalog number MRXP 200 and specific serial numbers listed in the recall notice.
The MEDRAD MRXperion MR Injection System is a syringe-based fluid delivery system indicated for the delivery of contrast media and saline during magnetic resonance imaging (MRI) applications. It is intended for use by trained healthcare professionals to inject intravenous MR contrast media and saline into the human vascular system for diagnostic studies. The devices were distributed worldwide and in the US state of New York.
Healthcare facilities should stop using the affected devices and contact Bayer Healthcare for further instructions. Consumers should not use these devices if they are in their possession.
The recalled product
- 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…
- Manufacturer
- Bayer Healthcare
- Hazard
- Affected units
- 42
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
Distributed in 1 state:
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