Class 2 Device Recall

• Date Initiated by Firm: August 08, 2003
• Date Posted: August 21, 2003
• Recall Status: Terminated on February 19, 2004
• Recall Number: Z-1145-03
• Recall Event ID: 26933
• Product Classification: Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) - Product Code MHX
• Product: Integris Monitor Arm; model P997-04
• Code Information: All units manufactured prior to June 20, 2003.
• FEI Number: 1824206
• Recalling Firm/ Manufacturer: Hill-Rom Co., Inc.; 3 West Pearl St; Batesville IN 47006
• For Additional Information Contact: Technical support; 800-445-3720
• Manufacturer Reason for Recall: The monitor may separate from the monitor arm, allowing the monitor to fall from the arm.
• FDA Determined 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: 2778
• 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

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.