| Class 2 Device Recall MUSE Cardiology Information System | |
Date Initiated by Firm | March 16, 2022 |
Create Date | April 13, 2022 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-0919-2022 |
Recall Event ID |
89834 |
510(K)Number | K152993 |
Product Classification |
Computer, diagnostic, programmable - Product Code DQK
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Product | MUSE Cardiology Information System, Model Numbers: a) 3101011-040, b) 3101010-401, c) 3101010-009, d) 3101010-008 |
Code Information |
a) 3101011-040, UDI (01)00840682142809(10)MUSENXSP2, Serial Numbers: SSR20435644TA, SSR20085352TA, SSR19455267TA, SSR20245386TA, SSR20225354TA, SSR20235322TA, SSR19485286TA, SSR20265441TA, SSR20435653TA, SSR20235349TA, SSR20315513TA, SSR20045337TA, SSR19415230TA, SSR19425238TA; UDI (01)00840682142809(10)MUSENXSP3, Serial Numbers: SSR19305164TA, SSR21255865TA, SSR20525351TA, SSR20525347TA, SSR20325524TA, SSR21326015TA, SSR21025368TA, SSR21065487TA, SSR19395224TA; UDI (01)00840682142809(10)MUSENXSP4, Serial Numbers: SSR19445252TA, SSR21035400TA, SSR21536318TA, SSR22056438TA, SSR20225343TA, SSR20515315TA, SSR20265429TA, SSR20465706TA, SSR20315501TA b) 3101010-401, UDI (01)00840682142809(10)MUSENXSP2, Serial Numbers: SSR19305178TA, SSR19265115TA, SSR20315505TA, SSR20405600TA, SSR20415608TA, SSR20255413TA, SSR20385590TA, SSR20265439TA, SSR19485282TA, SSR19435251TA, SSR20235360TA, SSR20125313TA, SSR20325529TA, SSR20125350TA, SSR19445257TA, SSR20035336TA, SSR19515306TA, SSR19415228TA, SSR20235369TA, SSR20355576TA, SSR20515344TA, SSR20225349TA, SSR20415610TA, SSR20335533TA, SSR20235365TA, SSR20425623TA, SSR19525317TA, SSR20235346TA; UDI (01)00840682142809(10)MUSENXSP3, Serial Numbers: SSR21185714TA, SSR19285150TA, SSR21085519TA, SSR21356058TA, SSR20455682TA, SSR21215784TA, SSR21275895TA, SSR21285908TA, SSR21205767TA, SSR20295480TA, SSR21045424TA, SSR21175691TA, SSR21055448TA, SSR19355213TA, SSR21065475TA, SSR21055459TA, SSR21165669TA, SSR21185705TA, SSR21195741TA, SSR21125596TA, SSR21235844TA, SSR20465707TA, SSR21315999TA, SSR21426117TA, SSR21155657TA, SSR21426114TA, SSR21035404TA, SSR21295941TA, SSR20235345TA, SSR21055456TA, SSR20315499TA, SSR20315500TA, SSR20275464TA, SSR21185719TA, SSR21185720TA, SSR21386052TA, SSR21386053TA, SSR21386054TA, SSR21436118TA, SSR21436122TA, SSR21436123TA, SSR20235325TA, SSR21185731TA, SSR20315494TA, SSR20315493TA, SSR20265446TA, SSR21356057TA; UDI (01)00840682142809(10)MUSENXSP4, Serial Numbers: SSR21476197TA, SSR21305971TA, SSR21506267TA, SSR21185730TA, SSR21396072TA, SSR21486216TA, SSR21476205TA, SSR21356047TA, SSR21215780TA, SSR21506263TA, SSR21225815TA, SSR21496242TA, SSR21526307TA, SSR19505289TA, SSR21516287TA, SSR22046398TA, SSR21516281TA, SSR21526299TA, SSR21416095TA, SSR21235846TA, SSR21336022TA, SSR20295484TA, SSR21275889TA, SSR21496247TA, SSR22096508TA, SSR21506252TA, SSR21466153TA, SSR22066453TA; c) 3101010-009, UDI (01)00840682142809(10)MUSENXSP3, Serial Numbers: SSR21095569TA, SSR21135614TA, SSR21025386TA; UDI (01)00840682142809(10)MUSENXSP4, Serial Numbers: SSR22026369TA, SSR22046388TA; d) 3101010-008, UDI (01)00840682142809(10)MUSENXSP2, Serial Numbers: SSR20235354TA, SSR20505775TA, SSR20255408TA; UDI (01)00840682142809(10)MUSENXSP3, Serial Numbers: SSR21366065TA, SSR21065468TA, SSR21316007TA; UDI (01)00840682142809(10)MUSENXSP4, Serial Numbers: SSR21486211TA |
Recalling Firm/ Manufacturer |
GE Healthcare, LLC 3000 N Grandview Blvd Waukesha WI 53188-1615
|
For Additional Information Contact | GE Healthcare Service 800-437-1171 |
Manufacturer Reason for Recall | Two scenarios may cause edits to measurements and diagnosis statements can be lost after a test is Signed in the MUSE NX web client. |
FDA Determined Cause 2 | Software Manufacturing/Software Deployment |
Action | GE Healthcare notified its consignees by letter titled URGENT MEDICAL DEVICE CORRECTION on March 16, 2022. The letter explained the two scenarios which would produce the loss of edits and provided recommendations and a workaround. The firm will correct all affected products at no cost to you. The firm will be issuing a software patch. A GE Healthcare representative will contact affected customers to arrange for the correction. If you have any questions or concerns regarding this notification, contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative |
Quantity in Commerce | 147 units |
Distribution | US and Australia, Austria, Bahrain, Belgium, Brazil, Canada, Denmark, England, France, Germany, Ireland, Italy, Korea, Malaysia, Netherlands, Norway, Poland, Qatar, Saudi Arabia, Singapore, Spain, Sweden, Taiwan, Turkey |
Total Product Life Cycle | TPLC Device Report |
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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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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510(K) Database | 510(K)s with Product Code = DQK
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