Recall Z-1380-2018 ยท MEC Disinfector, Medical Devices
Getinge Disinfection Ab
Getinge AGS, FSLC, FSUC, RC accessory to Washer- Disinfector 88 Series UDI Info: 07340153700109, 07340153700116 Getinge automated loading/unloading systems are intended to be used as an automatic conveyor/transport system for unloading carriers (wash carts) from Getinge 86/88 series Washer-disinfectors. The automated loading/unloading systems in no way affect the cleaning/disinfection performanc
| Date | Mar 2, 2018 |
| Status | Terminated |
| Reason | There is potential for a cart with disinfected goods to unload without the trolley being docked. Disinfected goods could end up falling to the floor causing risk to nearby users and damage to goods and equipment. |
| Root cause | Software design |
| Action | A letter (Urgent Medical Device Recall Notice) was issued March 2, 2018 via 2 Day Fedex with customer signature required to allow for tracking of delivery. The letter includes a customer response form requesting feedback including if device is still in use at the facility. The letter instructs the customer to contact Getinge Service to schedule a visit and service by a trained Getinge technician at no charge to the customer. In addition Getinge Service will proactively contact affected customers and perform the correction when affected installed devices are identified. Recalled product will b |
| Quantity | 170 total products |
| Distribution | Worldwide Distribution - USA (nationwide) and the following countries: AUSTRALIA, BELGIUM, BRAZIL, CANADA, CHINA, COLOMBIA, CZECH REPUBLIC, GERMANY, DENMARK, NETHERLANDS, NORWAY, SPAIN, FINLAND, FRANCE, GREAT BRITAIN, HONG KONG, ITALY, JAPAN, KOREA, KUWAIT, MALAYSIA, NORWAY, NEW ZELAND, SAUDI ARAB |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.