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ALPHAMAXX mobile operating table recallZ-2272-2024 · Getinge Usa Sales Inc · initiated May 29, 2024

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Getinge Usa Sales Inc or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Component design/selection

What the company is doing

On May 29, 2024 URGENT MEDICAL DEVICE CORRECTION letters were sent to customers. Actions to be taken by the Customer: Our records indicate that you have received one or more of the ALPHAMAXX Mobile Operating Table from the affected Product Code/Part Number 1133.22F5. Please examine your inventory immediately to determine if you have any of the ALPHAMAXX Mobile Operating Table (1133.22F5) with the Product REF number listed in this notice. The device can be used in accordance with the instructions for use, with extra attention to the following: 1. The battery status is displayed on the override panel of the operating table (IFU113322XYEN18_01 - 4.3 Override control panel). This is visible to the user at any time. 2. It is pointed out in the instruction for use (IFU113322XYEN18_01 5.2.4 Battery operation) that the operating table should be charged when the battery status is low. Whether or not you have affected product(s) with the Product REF numbers, please complete, and sign the attached MEDICAL DEVICE CORRECTION RESPONSE FORM to acknowledge that you have received this notification. Return the completed form to Getinge by e-mailing a scanned copy to [email protected] or by faxing the form to 1- 866- 575- 5658. Please forward this information to all current and potential ALPHAMAXX Mobile Operating Table users within your hospital/facility. If you are a distributor who has shipped any affected products to customers, please forward this document to their attention for appropriate action. Type of Action by Maquet/Getinge: *Maquet/Getinge has developed a solution that will correct this issue. A Getinge Service Representative will contact you to schedule the correction. This work will be done at no cost to your facility. Adverse reactions or quality problems experienced with the use of any of the products identified on Pages 1 and 2 may be reported to the FDA s MedWatch Adverse Event Reporting program either online, by regular mail or by fax usi

Recall details

Recall number
Z-2272-2024
Status
Open, Classified
Initiated by the company
May 29, 2024
Posted by the FDA
Jul 5, 2024
Recalling firm
Getinge Usa Sales Inc
Quantity
171 Units
Product code
FQO
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.

Product description

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

Code information (models, lots, serial numbers)

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

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other products in the same recall event

The FDA groups related products into one recall event (event 94740).

Sources and updates

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