FDA Medical Device Recalls (openFDA)
Maquet Cardiovascular Us Sales, Llc: Getinge 46-Series Washer Disinfector Model # 46-4, Part Number:46-4-502 Product Usage: Used in facilities such as Central Sterile Supply Departments, next to the Operating Room, in dental clinics or hospital wards to clean, thermally or chemically disinfect and dry surgical goods.
- Recall number
- Z-1390-2020
- Recalling firm
- Maquet Cardiovascular Us Sales, Llc
- Product
- Getinge 46-Series Washer Disinfector Model # 46-4, Part Number:46-4-502 Product Usage: Used in facilities such as Central Sterile Supply Departments, next to the Operating Room, in dental clinics or hospital wards to clean, thermally or chemically disinfect and dry surgical goods.
- Status
- Terminated
- Initiated
- 2020-01-16
- Posted
- not on file
- Terminated
- 2023-10-23
- Reason
- Due to a missing water intake for Deionized water on the Getinge 46-Series Washer Disinfector. There were no valve, hose, or clamps for this option included with the device therefore the units could not be properly installed. There have been no adverse events reported resulting in serious illness or injuries.
- Root cause
- Employee error
- Action
- Getinge issued an Urgent Medical Device Recall Correction letter to U.S. consignees via FedEx Priority Overnight delivery with signature proof of delivery on January 16, 2020. Letter provides identification of the issue, health risk and action to take. Customers were advised to examine your inventory immediately, complete and sign the MEDICAL DEVICE RECALL - RESPONSE FORM to acknowledge that you have received this notification, return the completed form to Getinge Disinfection AB by e-mailing a scanned copy to swic46-series.us@getinge.com or by faxing the form to 1-800-574-5051. Should you have one or more Getinge 46-Series Washer Disinfectors (models 46-4-502 and 46-4-503) you will be contacted by a Getinge Service Representative to schedule on-site service of your device, free of charge, by a Getinge Service Representative. You can also arrange a visit by a Getinge trained or authorized service technician by contacting Getinge Customer Technical Support at (888) 9438872 (select option 1, then option 2), Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. (Eastern Time Zone). If you are a distributor who has shipped any affected products to customers, please forward this document to their attention for appropriate action.
- Quantity
- 4 units
- Distribution
- U.S. Distribution: CA, CO, IA, MN, NY, SC, VA
- Lot, serial or model codes
- Serial Numbers: WAA090630, WAA090724, WAA091212, WAA091456, WAA091468, WAA092596. UDI Code 07340153700031
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- MEC
- Firm FEI
- 3013876692
- Firm city
- Wayne
- Firm state
- NJ
- 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