Recall Z-1475-2020 ยท MEC Disinfector, Medical Devices
Maquet Cardiovascular Us Sales, Llc
Getinge 88-Series-washer disinfectors intended for cleaning, disinfection and drying Model Number: 88-5 Part Number: 88-103; 88-203
| Date | Feb 18, 2020 (initiated Feb 10, 2020) |
| Status | Terminated |
| Reason | 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 |
| Root cause | Device Design |
| Action | 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 reco |
| Quantity | 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, Lithuania, Netherlands, New Zealand, Norway, Poland, Qatar, Saudi Arabia, Singapore, Slovenia, South K |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.