Arjo Concerto Basic Shower Trolley Recalled for Loose Bolts
Arjo is recalling 1,596 Concerto Basic Shower Trolleys because bolts connecting the stretcher to the hydraulic piston and tilting mechanism may become loose.
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: The recall involves a structural defect (loose bolts) in a medical device used for patient handling, which poses a risk of harm if the stretcher fails, but the source text does not report any specific injuries or fatalities.
Plain-English summary
Arjo, Inc. dba ArjoHuntleigh is recalling 1,596 units of the Concerto Basic Shower Trolley. This medical device is intended for assisted hygiene care, specifically showering and bathing residents in care environments such as senior living facilities, nursing homes, hospitals, and home care settings. The affected units were manufactured by ArjoHuntleigh Polska Sp. z o.o. between March 7, 2014, and April 20, 2015, and have serial numbers ranging from P0227559 to P0322393.
The recall is due to reports that the bolts connecting the stretcher to the hydraulic piston and the stretcher tilting mechanism may become loose. This defect could potentially compromise the stability of the device during use. The affected units were distributed to consignees in the United States and various foreign countries, including Canada, the United Kingdom, and numerous European and Asian nations.
Consumers and healthcare facilities should stop using the affected shower trolleys immediately. Users should check the serial number on their device to determine if it is within the affected range. For more information or to arrange for a repair or replacement, users should contact Arjo, Inc. dba ArjoHuntleigh.
The recalled product
- Product
- The Concerto Basic Shower Trolley is intended for assisted hygiene care, especially showering and bathing of residents in care environments such as senior/assisted living, group home, special care, nursing homes, hospitals and home care. The Concerto Basic Shower Trolley is…
- Manufacturer
- Arjo, Inc. dba ArjoHuntleigh
- Affected units
- 1,596
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- March 7
- 2014 through April 20
- 2015 with serial numbers from P0227559 - P0322393
Distribution
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