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Class 2 Device Recall |
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Date Initiated by Firm |
August 08, 2003 |
Date Posted |
August 21, 2003 |
Recall Status1 |
Terminated 3 on February 19, 2004 |
Recall Number |
Z-1299-03 |
Recall Event ID |
26933 |
Product Classification |
Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) - Product Code MHX
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Product |
Integris Monitor Arm, model P997-03. |
Code Information |
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. |
Recalling Firm/ Manufacturer |
Hill-Rom Co., Inc. 3 West Pearl St Batesville IN 47006
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For Additional Information Contact |
Technical support 800-445-3720
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Manufacturer Reason for Recall |
The monitor may separate from the monitor arm, allowing the monitor to fall from the arm.
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FDA Determined Cause 2 |
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. |
Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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