Bariatric ceiling-mounted lift spreader bar can disconnect from scale attachment
Arjohuntleigh recalls 62 Maxi Sky 1000 and V10 bariatric ceiling lifts because the spreader bar can disconnect from the scale attachment. Users should immediately stop using affected units and contact the manufacturer.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This FDA Class II medical device recall addresses a mechanical failure (spreader bar disconnection) that poses a potential fall risk to patients using the equipment. No injuries or illnesses are reported in the source material, placing this in the risk-of-harm category without confirmed harm per the severity rubric.
Plain-English summary
Arjohuntleigh Magog, Inc. is recalling the Maxi Sky 1000 (Arjo) and V10 (BHM) bariatric ceiling rail-mounted lifts with measuring function. A total of 62 units are affected by this recall.
The spreader bar can disconnect from the scale bottom attachment. This mechanical defect creates a potential safety risk during equipment operation.
The recalled units were distributed in the United States to facilities in Arizona, California, Colorado, Illinois, Louisiana, Massachusetts, Michigan, Missouri, Ohio, Pennsylvania, and Washington. The affected models are 700-00536 and 700-00526, both with 454 kg scales.
Customers using these lifts should immediately discontinue use of affected units and contact Arjohuntleigh Magog, Inc. for instructions on repair, replacement, or return of the equipment.
The recalled product
- Product
- Maxi Sky 1000 (Arjo) and V10 (BHM) Bariatric Ceiling Rail - Mounted Lift with measuring function
- Manufacturer
- Arjohuntleigh Magog, Inc.
- Affected units
- 62
Distribution
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