Z-1248-2022Class II

Getinge CM320-2 CHAMBER WU Series Washer Disinfector- For Use as a multi-chamber washer-disinfector for the...

Name: Z-1248-2022 Getinge CM320-2 CHAMBER WU Series Washer Disinfector- For Use as a multi-chamber washer-disinfector for the...
Creator: Getinge Usa Sales Inc
Published: 2022-04-13
License: https://open.fda.gov/license/

Maquet Cardiovascular Us Sales, LLC / initiated 2022-04-13 / Open, Classified / root cause: manufacturing process

FDA source

Getinge Usa Sales Inc began a recall of Getinge CM320-2 CHAMBER WU Series Washer Disinfector- For Use as a multi-chamber washer-disinfector for the washing, disinfecting and drying surgical... on 2022-04-13. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1248-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-04-13
Posted: 2022-06-08
Recalling firm: Maquet Cardiovascular Us Sales, LLC
Product: 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
Product code: MEC Disinfector, Medical Devices
Reason for recall: 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
Root cause tag: manufacturing process
FDA root cause: Process control
Action: 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].
Quantity in commerce: 4 units
Distribution: US Nationwide distribution in the states of MD, MN, ND, NE, NY, PA, VA.
Product codes and lots: UDI-DI: 07340153700185 Serial Numbers: W50034570 WAA070170 WAA070618 WAA081312

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1248-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1248-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-06-15	2022-06-08
Z-1249-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-06-15	2022-06-08

Product code MEC

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)