Veris Invasive Blood Pressure Interface Cables-Part # 3010478. The product is an accessory to patient physiological moni
FDA device recall Z-0259-2007 · posted 2006-12-15 · Terminated
Recall details
- Recalling firm
- Medrad Inc
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- MWI
- Quantity affected
- 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.
- Date initiated
- 2006-09-29
- Date posted
- 2006-12-15
- Date terminated
- 2007-06-20
- Location
- Indianola, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| 8600 VITAL SIGNS MONITOR (K042569) | Criticare Systems, Inc. | 2004-09-29 |