GETINGE CM320-SERIES recallZ-1248-2022 · Getinge Usa Sales Inc · initiated Apr 13, 2022
Open, Classified
Is my device affected?
- 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.
- 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.
- 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
Verification of installation not documented or may be incomplete, could result in harm to the user such as skin burns, smoke inhalation, electric shock, or a crush or pinch injury or slip and fall injury. May lead to a patient procedural delay and/or infection
FDA root cause category: Process control
What the company is doing
Getinge issued to U.S. consignees Medical Device Correction Letter dated April 13, 2022 via FedEx delivery. Letter states reason for recall, health risk and action to take: Please examine your inventory immediately to determine if you have any Getinge CM320-series Washer Disinfectors with the REF number/serial numbers listed on page 1. You can continue to use Getinge CM320-series Washer Disinfectors until the corrective action is performed; there are no precautionary actions necessary. 2. Please complete and sign the attached MEDICAL DEVICE CORRECTION - RESPONSE FORM (page 5) to acknowledge that you have received this notification. A Getinge service technician will review the Installation Checklist and verify that each of the steps were performed to ensure continual safe operation of your cart washer(s). This review and verification will be performed. Questions contact your Getinge representative or Technical Support please call (888) 943-8872 (options 4,2,1), Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. (Eastern Time Zone). Technical Support can also be reached via email at [email protected].
Recall details
- Recall number
- Z-1248-2022
- Status
- Open, Classified
- Initiated by the company
- Apr 13, 2022
- Recalling firm
- Getinge Usa Sales Inc
- Quantity
- 4 units
- Product code
- MEC
- Distribution
- US Nationwide distribution in the states of MD, MN, ND, NE, NY, PA, VA.
Product description
Getinge CM320-2 CHAMBER WU Series Washer Disinfector- For Use as a multi-chamber washer-disinfector for the washing, disinfecting and drying surgical instruments, etc. Model: CM320 WU
Code information (models, lots, serial numbers)
UDI-DI: 07340153700185 Serial Numbers: W50034570 WAA070170 WAA070618 WAA081312
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- GETINGE CM320-SERIESGetinge Disinfection AB · Disinfector, Medical Devices2 recalls1 report
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 90146).
- Z-1249-2022 · Open, ClassifiedGetinge CM320 WUWD Series Washer Disinfector-For use as a multi-chamber washer-disinfector for the washing, disinfecting and drying surgical instruments, Model: CM320 WUWD
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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