Hill-Rom Co., Inc. began a recall of Integris Monitor Arm, model P997-03 on . The reason FDA records is "The monitor may separate from the monitor arm, allowing the monitor to fall from the arm". As of , the recall status on record is Terminated.
Recall record
- Recall number
- Z-1299-03
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Hill-Rom Inc.
- Product
- Integris Monitor Arm, model P997-03.
- Product code
- MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
- Reason for recall
- The monitor may separate from the monitor arm, allowing the monitor to fall from the arm.
- FDA root cause
- Other
- Action
- 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.
- Quantity in commerce
- 757
- Distribution
- United States, Belgium, Canada, China, Egypt, Hong Kong, Japan, Mexico, Paraguay, Saudi Arabia, Switzerland, Taiwan, Turkey, United Arab Emirates and United Kingdom.
- Product codes and lots
- All units distributed prior to June 20, 2003 are affected when used with the P997-11, or the P997A11, accessories allowing for equipment [ satellite racks, CPU's, keyboards, or other equipment] to be installed below the arm.
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