Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1299-03

Integris Monitor Arm, model P997-03

Hill-Rom Inc. / initiated 2003-08-08 / Terminated

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.