FDA Medical Device Recalls (openFDA)
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
- Recall number
- Z-1233-2008
- Recalling firm
- Arjo, Inc.
- Product
- 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
- Status
- Terminated
- Initiated
- 2008-02-20
- Posted
- 2008-07-18
- Terminated
- 2010-09-11
- 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 customer response form, acknowledging the receipt and understanding of the letter, and indicating the number of units requiring correction.
- Quantity
- 25 units
- Distribution
- Nationwide Distribution.
- Lot, serial or model codes
- There are no serial numbers on the BHM Medical Infrared (IR) Hand Control System, part 700.13640.33 - IR hand control, and part 492.00038 - IR receiver board. The hand controls were installed on the following ceiling lifts: i) Maxi Sky 600, part LD10111, serial numbers LD-2605-15164, LD30733967, LD30733968, LD480627315, LD-5105-21404; ii) V4, part 9100021, serial numbers V4-1107-29534, V4-1307-29837, V4-3307-33778, V4-1507-30147, V4-1905-14715, V4-4205-18404, V4-3606-26259, LD-1706-24108, V4-0206-22026, V4-3405-16157, V4-4606-27188, V4-4803-04671, V4-1307-29838, V4-1806-24149, V4-3307-33779, V4-4207-36144; part 9100021.13, serial numbers V4-0805-09557, V4-1006-23261; part 9100023, serial number V4-1406-23773; and part 9101021, serial number V4-0105-08044.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FNG
- Firm FEI
- 1419652
- Firm city
- Roselle
- Firm state
- IL
- 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
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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