FDA Medical Device Recalls (openFDA)
Getinge Disinfection: Getinge 46-Series Medical Washer-Disinfectors, Listing # E208196 Product Usage: The washer disinfector is used in healthcare facilities where reusable items such as instruments, utensils, anesthesia sets, and glassware are handled for decontamination purposes.
- Recall number
- Z-0018-2014
- Recalling firm
- Getinge Disinfection
- Product
- Getinge 46-Series Medical Washer-Disinfectors, Listing # E208196 Product Usage: The washer disinfector is used in healthcare facilities where reusable items such as instruments, utensils, anesthesia sets, and glassware are handled for decontamination purposes.
- Status
- Terminated
- Initiated
- 2013-07-30
- Posted
- 2013-10-17
- Terminated
- 2015-05-11
- Reason
- Getinge Disinfection AB initiated a voluntary field safety correction for the Getinge 46-Series electrically-heated Washer Disinfectors due to possible overheating.
- Root cause
- Nonconforming Material/Component
- Action
- Getinge USA, Inc. sent a Device Correction Notices letter dated July 26, 2013 to all affected customers via US Postal Certified Mail within the U.S. and Canada. The letter identified the affected product, problem and actions to be taken. The letter indicate that all customers will be contacted by a Getinge representative for guidance if any machine within the serial number range of affected product is within their possession. If you should have any questions or concerns regarding this field correction, please call 1-800-475-9040, press "1" and enter extension 5036.
- Quantity
- 143 units (142 domestically & 1 unit internationally)
- Distribution
- USA Nationwide in the states of AL, AR, AZ, CA, CO, FL, GA, HI, IA, ID, IL, IN, KS, LA, MA, MD, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY and internationally in Canada.
- Lot, serial or model codes
- Model # 46-4, Serial # range SEV0521184-SEV0838137
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- MEC
- Firm FEI
- 3000231474
- Firm city
- Vaxjo
- Firm state
- not on file
- Firm country
- Sweden
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