Z-1233-2008

BHM Medical Infrared (IR) Hand Control System, an optional wireless control component of the Arjo Maxi Sky...

Name: Z-1233-2008 BHM Medical Infrared (IR) Hand Control System, an optional wireless control component of the Arjo Maxi Sky...
Creator: Arjo, Inc.
Published: 2008-02-20
License: https://open.fda.gov/license/

Arjo, Inc. / initiated 2008-02-20 / Terminated / root cause: design

FDA source

Arjo, Inc. began a recall of 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... on 2008-02-20. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1233-2008
Status: Terminated
Initiated: 2008-02-20
Posted: 2008-07-18
Terminated: 2010-09-11
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
Product code: FNG Lift, Patient, Ac-Powered
Reason for recall: 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 tag: design
FDA 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 in commerce: 25 units
Distribution: Nationwide Distribution.
Product codes and lots: 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.

Product code FNG

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)