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Terminated

Integris Monitor Arm, model P997-01.

FDA Recall Z-1298-03 · Posted 2003-08-21

Recalling FirmHill-Rom Co., Inc.
Recall StatusTerminated
Product CodeMHX
Date Initiated2003-08-08
Date Terminated2004-02-19
Product Quantity700

Reason for Recall

The monitor may separate from the monitor arm, allowing the monitor to fall from the arm.

Firm 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.

Root Cause

Other

Distribution Pattern

United States, Belgium, Canada, China, Egypt, Hong Kong, Japan, Mexico, Paraguay, Saudi Arabia, Switzerland, Taiwan, Turkey, United Arab Emirates and United Kingdom.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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