Integris Monitor Arm, model P997-03.
FDA device recall Z-1299-03 · posted 2003-08-21 · Terminated
Recall details
- Recalling firm
- Hill-Rom Co., Inc.
- Reason for recall
- The monitor may separate from the monitor arm, allowing the monitor to fall from the arm.
- Action taken
- An Urgent Device Correction letter dated 8/8/03 was sent to each hospital account receiving these products. The recall was extended to two additional products via a second letter issued on August 25, 2003. Hospitals were asked to take the units out of service, if possible, until Hill-Rom can inspect/correct them.
- Root cause
- Other
- Status
- Terminated
- Product code
- MHX
- Quantity affected
- 757
- Distribution
- United States, Belgium, Canada, China, Egypt, Hong Kong, Japan, Mexico, Paraguay, Saudi Arabia, Switzerland, Taiwan, Turkey, United Arab Emirates and United Kingdom.
- Date initiated
- 2003-08-08
- Date posted
- 2003-08-21
- Date terminated
- 2004-02-19
- Location
- Batesville, IN
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