FDA Medical Device Recalls (openFDA)
Getinge USA Inc: 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
- Recall number
- Z-2079-2012
- 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
- Status
- Terminated
- Initiated
- 2012-05-25
- Posted
- 2012-07-26
- Terminated
- 2016-05-18
- Reason
- 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
- 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
- 8 washers
- Distribution
- Worldwide Distribution - USA including Maryland, Indiana, New Mexico, Massachuesetts, Texas, Kansas and the country of Canada
- Lot, serial or model codes
- Serial numbers: W50024258; W50024259; W50026573; W50025790; W50017381; W50020296; W50028138; W50020952
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- MEC
- Firm FEI
- 3004147784
- Firm city
- Rochester
- Firm state
- NY
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28