FDA Medical Device Recalls (openFDA)
Getinge/Castle, Inc.: Model 8666 Washer/Disinfector with holding tank heater option. Firm on label is Getinge Disinfection AB, Vaxjo, Sweden.
- Recall number
- Z-0908-03
- Recalling firm
- Getinge/Castle, Inc.
- Product
- Model 8666 Washer/Disinfector with holding tank heater option. Firm on label is Getinge Disinfection AB, Vaxjo, Sweden.
- Status
- Terminated
- Initiated
- 2003-03-25
- Posted
- 2003-06-05
- Terminated
- 2004-01-14
- Reason
- Hot water may splash from the washer chamber creating a burn hazard.
- Root cause
- Device Design
- Action
- Letter dated 3/25/03 flagged: ''Important Safety Alert/Product Upgrade''. Customers advised to discontinue use until the field correction is performed.
- Quantity
- 75 units
- Distribution
- Nationwide. Medical facilities in AL, CA, CO, LA, MA, MI, MN, MO, NC, NH, NM, OK, PA, TX, WA, and WI.
- Lot, serial or model codes
- Serial numbers 81972 through 82063; and SEV0141098 through SEV0304112.
- 510(k) numbers
- ["K920413"]
- PMA numbers
- not on file
- Product code
- MEC
- Firm FEI
- 1314329
- 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