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Recall Observatory FDA recall evidence

Device product

ALPHAMAXX Mobile Operating Table, Model Number/Part Number: 113322B5

Z-2272-2024

May 29, 2024

Class II

Product summary

Firm
Getinge Usa Sales Inc
Event
Event 94740
Status
Ongoing
Classification
Class II
Quantity
171 Units
Official record key
device-enforcement:Z-2272-2024

Official wording

Reason: The recall is prompted by a defective charger unit (0970.2873) for models 1133.22B4, 1133.22B5, and 1133.22F5 of the ALPHAMAXX mobile operating table. This issue poses a risk of inadequate charging and operational failure.

Code information: Model Number/Part Number: 113322B5; UDI/DI: 04046768040014; Serial Numbers: 2059 through 2183, 2185 through 2204, 2206, 2208, 2209, 2211 through 2231, 2233, 2235.

Distribution pattern: Domestic: KY, NC, NY, VA. International: 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, United Arab Emirates, United Kingdom.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The recall is prompted by a defective charger unit (0970.2873) for models 1133.22B4, 1133.22B5, and 1133.22F5 of the ALPHAMAXX mobile operating table. This issue poses a risk of inadequate charging and operational failure.