Recall Z-0259-2007 ยท MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Medrad Inc
Veris Invasive Blood Pressure Interface Cables-Part # 3010478. 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
| K042569 | 8600 VITAL SIGNS MONITOR Criticare Systems, Inc., Sep 29, 2004 |