ALPHAMAXX Mobile Operating Table, Model Number/Part Number: 113322F5
Summary
The FDA issued a Class II for ALPHAMAXX Mobile Operating Table, Model Number/Part Number: 113322F5 by Getinge Usa Sales Inc. 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..
Details
Source
Device Recall
External ID
Z-2273-2024
Action Date
2024-07-17
Status
Ongoing
Category
device
Product Description
ALPHAMAXX Mobile Operating Table, Model Number/Part Number: 113322F5
Lot/Code Info: Model Number/Part Number: 113322F5; UDI/DI: 04046768040052; Serial Numbers: 409 through 411, 413 through 416.
Quantity Affected: 7 units
Reason for Recall
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.
Distribution
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-05-29
Company
Wayne, NJ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 188 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Getinge Usa Sales Inc has 48 FDA actions in our database, including 48 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Getinge Usa Sales Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Getinge Usa Sales Inc have FDA actions?
Getinge Usa Sales Inc has 48 FDA actions in our database, including 48 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2273-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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