Recall Z-0258-2007 ยท MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Medrad Inc
Invasive Blood Pressure Interface Cables: a) Medrad 9500 Multigas monitor for MRI, Invasive Blood Pressure Interface Cable (Part # 3006314) for use with Abbott/Hospira IBP Transducer b) Invasive Blood Pressure Interface Cable (Part # 3008772) for use with Braun IBP Transducers. The product is an accessory to patient physiological monitor.
| Date | Dec 15, 2006 (initiated Sep 29, 2006) |
| Status | Terminated |
| Reason | Interference problems: certain invasive blood pressure transducers connected to these cables are susceptible to interference if exposed to static magnetic field strengths exceeding 300 gauss. In certain orientations, the transducer causes the invasive blood pressure readings on the physiological monitor to display inaccurate readings. |
| Root cause | Other |
| Action | The recalling firm contacted all affected customers via telephone or letter dated November 20, 2006 to inform them of the problem and instruct them to return the cables or apply corrective labeling. |
| Quantity | 80 units |
| Distribution | Worldwide distribution ---- including USA state of CA, CO, HI, IL, IN, MA, MD, NJ, NY, OH, PA, TX, and WA and countries of The Netherlands, Denmark, Australia, Brazil, Italy, and Japan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K983250 | INVASIVE BLOOD PRESSURE (IBP) FUNCTION, MODEL 9500 MULTIGAS MONITOR Magnetic Resonance Equipment Corp., Dec 12, 1999 |