FDA Medical Device Recalls (openFDA)
Hill-Rom Co., Inc.: Integris Monitor Arm, model P997-03.
- Recall number
- Z-1299-03
- Recalling firm
- Hill-Rom Co., Inc.
- Product
- Integris Monitor Arm, model P997-03.
- Status
- Terminated
- Initiated
- 2003-08-08
- Posted
- 2003-08-21
- Terminated
- 2004-02-19
- Reason
- The monitor may separate from the monitor arm, allowing the monitor to fall from the arm.
- 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
- 757
- Distribution
- United States, Belgium, Canada, China, Egypt, Hong Kong, Japan, Mexico, Paraguay, Saudi Arabia, Switzerland, Taiwan, Turkey, United Arab Emirates and United Kingdom.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- MHX
- Firm FEI
- 1824206
- Firm city
- Batesville
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28