Food, drugs, devices › Bayer Healthcare
Device recall: Angiographic Injector and Syringe, MEDRAD MRXperion MR Injection System, MEDRAD MRXperion Sterile Disposable MRI Kit Usa
FDA enforcement event 74513 is a device recall by Bayer Healthcare of Indianola, PA, initiated 9 Jun 2016 and classified Class II, with 1 product record.
FDA defines Class II as 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. 91% of the 1,232 device enforcement events initiated in 2016 carry the same class.
Status: Terminated, terminated 5 Dec 2016. Initiation: voluntary: firm initiated. Bayer Healthcare has 6 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Bayer Healthcare, Indianola, PA.
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."
Distribution
"Worldwide and the US state of NEW YORK"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2244-2016 | 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… | 42 units | Class II | Terminated | 27 Jul 2016 |
Context
Other enforcement events for Bayer Healthcare
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 7 Nov 2016 | MEDRAD Intego PET Infusion System - Pump Intended to deliver accurate doses of Fluoredeoxyglucose or F-Sodium Fluoride a | Device | Class II | 1 |
| 30 Sep 2016 | PET Infusion Pump | Device | Class II | 1 |
| 2 Aug 2016 | Certegra Workstation used in conjunction with Medrad Stellant CT Injection System Catalog Number # CWKS DISPLAY Serial N | Device | Class II | 1 |
| 30 Nov 2015 | Medrad Source Administration Sets, Catalog number INT CSS. For use with MEDRAD Intego PET Infusion pump Systems, in nucl | Device | Class II | 1 |
| 4 Aug 2015 | Angiographic Injector. Medrad Mark 7 Arterion Injection System, which utilizes Software Version SW 005.006_SH; to be use | Device | Class II | 1 |
All 6 events for Bayer Healthcare
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "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."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. 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.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide and the US state of NEW YORK"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 5 Dec 2016. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.