Reported Jul 27, 2016 · Terminated
Angiographic Injector and Syringe, MEDRAD MRXperion MR Injection System, MEDRAD MRXperion Sterile Disposable MRI Kit…
Bayer Healthcare
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Bayer Healthcare · 1 Bayer Dr · Indianola, PA · 15051-9702
Is this the product you have?
- Angiographic Injector and Syringe, MEDRAD MRXperion MR Injection System, MEDRAD MRXperion
- Sterile Disposable MRI Kit UsageThe 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
- Lot codes and dates
- Catalog numbersMRXP 200
- Serial numbers
100009100011100019100020100022100026100027100028100036100047100065100066100069100074100075100085100090100091100096100097100098100099100100100101100103100104100106100107100108100109100110100111100112100113100114100118100119100129100152100155100161100166
- Amount recalled
- 42 units
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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