Recall Z-0919-2022
GE Healthcare, LLC · initiated March 16, 2022
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
MUSE Cardiology Information System, Model Numbers: a) 3101011-040, b) 3101010-401, c) 3101010-009, d) 3101010-008
Codes / lots: 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:…
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: Software Manufacturing/Software Deployment
Action taken
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
Details
- Recall number
- Z-0919-2022
- Initiated
- March 16, 2022
- Terminated
- May 4, 2026
- Product code
- DQK – Computer, Diagnostic, Programmable
- Quantity
- 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
- Recalling firm
- GE Healthcare, LLC, Waukesha, WI