Recall Z-1233-2008 ยท FNG Lift, Patient, Ac-Powered
Arjo, Inc.
BHM Medical Infrared (IR) Hand Control System, an optional wireless control component of the Arjo Maxi Sky 600 and BHM V4 Ceiling Patient Lifts; the hand control system is composed of two components, part 700.13640.33 - IR hand control, and part 492.00038 - IR receiver board
| Date | Jul 18, 2008 (initiated Feb 20, 2008) |
| Status | Terminated |
| Reason | The ceiling lift may not stop lateral movement after releasing the left (or right) action button on a ceiling lift equipped with an infrared hand control. |
| Root cause | Device Design |
| Action | Arjo sent Urgent Device Field Correction Notification letters dated 2/15/08 on the BHM Medical letterhead to the end user accounts who received the affected IR remotes, advising them of the potential for the remote to become difficult to operate or to create uncontrolled movement of the ceiling lift. The accounts were instructed to remove the IR remote from service until the field correction is issued by BHM Medical. Instructions for removal of the IR equipment were provided in the Safety Advisory Notice included with the letter. The accounts were requested to complete and return the enclosed |
| Quantity | 25 units |
| Distribution | Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.