Recall Z-1299-03 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Hill-Rom Co., Inc.
Integris Monitor Arm, model P997-03.
| Date | Aug 21, 2003 (initiated Aug 8, 2003) |
| Status | Terminated |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.