ALPHAMAXX Operating Table Defective Charger Recalled for Operational Failure Risk
Getinge Usa Sales Inc recalls 73 ALPHAMAXX mobile operating tables due to a defective charger unit that poses a risk of inadequate charging and operational failure.
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: FDA Class II recall of a risk-of-harm product (surgical operating table) where no injuries or illnesses have been reported. Per the severity rubric, recalls of medical devices presenting risk of harm with no documented injuries are classified as High.
Plain-English summary
Getinge Usa Sales Inc is recalling 73 units of the ALPHAMAXX Mobile Operating Table, Model 113322B4, due to a defective charger unit (part number 0970.2873). The defect affects multiple ALPHAMAXX models including 1133.22B4, 1133.22B5, and 1133.22F5.
The defective charger poses a risk of inadequate charging and operational failure of the operating table. These conditions could result in improper functioning of the device during use.
The affected units have been distributed domestically to healthcare facilities in Kentucky, North Carolina, New York, and Virginia. Internationally, units have been distributed to Australia, Bulgaria, Croatia, Czech Republic, Denmark, France, Greece, Hong Kong, Ireland, Israel, Japan, Jordan, Kuwait, Mexico, New Zealand, Norway, Poland, Romania, Saudi Arabia, South Africa, Spain, Switzerland, Thailand, the United Arab Emirates, and the United Kingdom. Affected serial numbers are 3018-3078, 3080-3086, 3088-3089, and 3095-3097.
The recalled product
- Product
- ALPHAMAXX Mobile Operating Table, Model Number/Part Number: 113322B4
- Manufacturer
- Getinge Usa Sales Inc
- Affected units
- 73
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 (6)
- Model Number/Part Number: 113322B4
- UDI/DI: 04046768040007
- Serial Numbers: 3018 through 3078
- 3080 through 3086
- 3088 through 3089
- 3095 through 3097.
Distribution
Part of a larger recall action
This product is one of 3 recalled by Getinge Usa Sales Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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