Class 2 Device Recall Getinge AGS, FSLC, FSUC, RC accessory to Washer Disinfector 86/88 Series

• Date Initiated by Firm: March 02, 2018
• Create Date: April 16, 2018
• Recall Status: Terminated on May 13, 2022
• Recall Number: Z-1380-2018
• Recall Event ID: 79641
• Product Classification: Disinfector, medical devices - Product Code MEC
• Product: 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 performance of the washer-disinfector. The automated loading/unloading equipment is considered an accessory to the medical washer-disinfector.
• Code Information: UDI Info: 07340153700109, 07340153700116 Serial Numbers: WAA075345 WAA059630 WAA060690 WAA061680 WAA062179 WAA062399 WAA062743 WAA062967 WAA064062 WAA064977 WAA071262 WAA076435 WAA078694 WAA080011 WAA080693 WAA070436 WAA080985 WAA61348 WAA61349 WAA058540 WAA058542 WAA058543 WAA058545 WAA059053 WAA059054 WAA061345 WAA061346 WAA061347 WAA061350 WAA061351 WAA061353 WAA062020 WAA062021 WAA062022 WAA062360 WAA062361 WAA062362 WAA062363 WAA062364 WAA062365 WAA063372 WAA063373 WAA063374 WAA069593 WAA074456 WAA063375 WAA081641 WAA081811 WAA081883 WAA081884 WAA083599 WAA062023 WAA066165 WAA066166 WAA066167 WAA066168 WAA056686 WAA057547 WAA058549 WAA058550 WAA058551 WAA058552 WAA058553 WAA058554 WAA059058 WAA059059 WAA060871 WAA060886 WAA060887 WAA060888 WAA060889 WAA060926 WAA060927 WAA060928 WAA060930 WAA061284 WAA061285 WAA061286 WAA061287 WAA061288 WAA061289 WAA061290 WAA061352 WAA062027 WAA062028 WAA062072 WAA062073 WAA062366 WAA062367 WAA062368 WAA062369 WAA062370 WAA062371 WAA063376 WAA063377 WAA063378 WAA063379 WAA065341 WAA065342 WAA065343 WAA065344 WAA065345 WAA065417 WAA065418 WAA065419 WAA066318 WAA066319 WAA066320 WAA066321 WAA069587 WAA069588 WAA069589 WAA069590 WAA069591 WAA069592 WAA073494 WAA078041 WAA069584 WAA078042 WAA078051 WAA081542 WAA081571 WAA081572 WAA081573 WAA081889 WAA081890 WAA081891 WAA081892 WAA077173 WAA081956 WAA081958 WAA081959 WAA081960 WAA059509 WAA059510 WAA059785 WAA060117 WAA061108 WAA061984 WAA062306 WAA062422 WAA062524 WAA062861 WAA062926 WAA064063 WAA064980 WAA066412 WAA069490 WAA070214 WAA070368 WAA071110 WAA071421 WAA071795 WAA075696 WAA076464 WAA079990 WAA078693 WAA080987 WAA077909 WAA080988
• Recalling Firm/ Manufacturer: Getinge Disinfection Ab; Ljungadalsgatan 11; Vaxjo Sweden
• For Additional Information Contact: Barb Smith; 585-214-6049
• Manufacturer Reason for Recall: 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.
• FDA Determined 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 be corrected by a trained Getinge Service Representative. The correction will involve a software update to remove any risk to operators. Additionally a preventive hardware update that provides a longer wearing end stop pin will be performed during the field correction. For further questions please call (585) 214-6049.
• Quantity in Commerce: 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 ARABIA, SWEDEN, SINGAPORE, SLOVENIA, THAILAND
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.