Z-2079-2012Class II

Getinge brand --- large capacity, floor loading jet spray, washers for mechanical washing, intermediate...

Name: Z-2079-2012 Getinge brand --- large capacity, floor loading jet spray, washers for mechanical washing, intermediate...
Creator: Getinge USA Inc
Published: 2012-05-25
License: https://open.fda.gov/license/

Getinge USA, Inc. / initiated 2012-05-25 / Terminated / root cause: manufacturing process

FDA source

Getinge USA Inc began a recall of Getinge brand --- large capacity, floor loading jet spray, washers for mechanical washing, intermediate level, thermal disinfection and drying of moisture and... on 2012-05-25. FDA classified it as Class II and gives the reason as "Getinge Disinfection AB is voluntarily correcting Washer Disinfectors, Getinge Electrically Heated 9100-Series manufactured between 2009-05-04 through 09-26-2011. This action is based on a report from the ground fault...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2079-2012
Classification: Class II
Status: Terminated
Initiated: 2012-05-25
Posted: 2012-07-26
Terminated: 2016-05-18
Recalling firm: Getinge USA, Inc.
Product: Getinge brand --- large capacity, floor loading jet spray, washers for mechanical washing, intermediate level, thermal disinfection and drying of moisture and temperature stable Hospital case carts, sterilization containers, material handling carts, stands and utensils. --- Model numbers Getinge 9120, 9122, 9125, and 9128
Product code: MEC Disinfector, Medical Devices
Reason for recall: Getinge Disinfection AB is voluntarily correcting Washer Disinfectors, Getinge Electrically Heated 9100-Series manufactured between 2009-05-04 through 09-26-2011. This action is based on a report from the ground fault breaker manufacturer of a production error.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Getinge USA issued a Device Correction Notice dated June 5, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were advised to perform a trip test to determine if they have a functioning ground fault breaker. Customers will be contacted by a Getinge representative to schedule an appointment to exchange the earth fault breaker. Customers were provided a Customer Response Form to complete and fax back to 585-272-5033. For questions customers should call 800-475-9040, ext. 5270. For questions regarding this recall call 585-475-1400.
Quantity in commerce: 8 washers
Distribution: Worldwide Distribution - USA including Maryland, Indiana, New Mexico, Massachuesetts, Texas, Kansas and the country of Canada
Product codes and lots: Serial numbers: W50024258; W50024259; W50026573; W50025790; W50017381; W50020296; W50028138; W50020952

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2079-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2079-2012	Class II	Terminated	Voluntary: Firm initiated	2012-08-01	2012-07-26

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)