Z-1391-2020Class III

Getinge 46-Series Washer Disinfector Model # 46-4, Part Number:46-4-503

Name: Z-1391-2020 Getinge 46-Series Washer Disinfector Model # 46-4, Part Number:46-4-503
Creator: Maquet Cardiovascular Us Sales, Llc
Published: 2020-01-16
License: https://open.fda.gov/license/

Maquet Cardiovascular Us Sales, LLC / initiated 2020-01-16 / Terminated / root cause: manufacturing process

FDA source

Maquet Cardiovascular Us Sales, Llc began a recall of Getinge 46-Series Washer Disinfector Model # 46-4, Part Number:46-4-503 Product Usage: Used in facilities such as Central Sterile Supply Departments, next to... on 2020-01-16. FDA classified it as Class III and gives the reason as "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...". 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-1391-2020
Classification: Class III
Status: Terminated
Initiated: 2020-01-16
Posted: 2020-02-27
Terminated: 2023-10-23
Recalling firm: Maquet Cardiovascular Us Sales, LLC
Product: Getinge 46-Series Washer Disinfector Model # 46-4, Part Number:46-4-503 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.
Product code: MEC Disinfector, Medical Devices
Reason for recall: 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 tag: manufacturing process
FDA 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 [email protected] 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 in commerce: 7 units
Distribution: U.S. Distribution: CA, CO, IA, MN, NY, SC, VA
Product codes and lots: Serial Numbers: WAA090094, WAA090112, WAA090409, WAA090521, WAA090757, WAA090805, WAA091170, WAA091288, WAA091292, WAA091454, WAA091460 WAA091463, WAA091477. UDI Code 07340153700048

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1391-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1390-2020	Class III	Terminated	Voluntary: Firm initiated	2020-03-04	2020-02-27
Z-1391-2020	Class III	Terminated	Voluntary: Firm initiated	2020-03-04	2020-02-27

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)