Getinge 88-Series-washer disinfectors intended for cleaning, disinfection and drying Model Number: 88-5 Part Number: 88-

FDA device recall Z-1475-2020 · posted 2020-02-18 · Terminated

Recall details

Recalling firm

Maquet Cardiovascular Us Sales, Llc

Reason for recall

Potential leakage that may occur due to ruptured spot welds in the chamber, could generate a situation for the user such as risk for slipping or infection from contaminated water

Action taken

Getinge issued letter dated 2/10/20 Letters via FedEx Priority Overnight Delivery with Signature Proof of Delivery (SPOD).Letter states reason for recall, health risk and action to take: Please examine your inventory immediately to determine if you have any affected Getinge 88-Series Washer Disinfectors (models 88-5) indicated by this notice; Once you have located the affected device, check to see if it is leaking underneath the machine or near the machines foot print. If the machine is leaking, call for Service Technician and plan for service. You can continue to use the machine but we recommend posting a sign for precaution. Units where leakage is observed will be prioritized in order to repair the unit. If your unit is found to be leaking due to this issue, it will be repaired free of charged. 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). Complete and sign the attached MEDICAL DEVICE RECALL - RESPONSE FORM (page 4) to acknowledge that you have received this notification.

Root cause

Device Design

Status

Terminated

Product code

MEC

Quantity affected

146 US

Distribution

Nationwide Foreign: Australia, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, Estonia, Finland, France, Germany, Hong Kong, India, Iraq, Iran, Ireland, Israel, Italy, Japan, Kenya, Li

Date initiated

2020-02-10

Date posted

2020-02-18

Date terminated

2023-09-13

Location

Wayne, NJ