Hemosphere System with the following three components: HEM1 Advanced Monitor, HEMSGM10 (Swan-Ganz Module), and HEMOXSC100 (Oximetry Smart Cable). Product Usage: The HemoSphere Advanced Monitor (HEM1) is intended to be used in combination with a compatible Edwards hemodynamic monitoring technology mo
Check against the official notice below — it lists the full affected range.
Edwards Lifesciences is recalling 198 units of its HemoSphe System, which includes the HEM1 Advanced Monitor, HEMSGM10 Swan-Ganz Module, and HEMOXSC100 Oximetry Smart Cable, due to pre-procedural issues related to software defects. The affected devices were distributed nationwide across Arizona, California, Colorado, Georgia, Illinois, Missouri, New Mexico, Oklahoma, Oregon, South Carolina, and Texas. Specific serial numbers for each component are identified in the recall, allowing facilities to determine if their devices are affected.
The recall notice does not specify a remedy for consumers or facilities with affected devices.
Written by software from the official notice below. Not reviewed by a lawyer.
Pre-procedural issues related to software defects
Reason for recall: Pre-procedural issues related to software defects Distribution: US Nationwide Distributed in the states of AZ, CA, CO, GA, IL, MO, NM, OK, OR, SC, TX Quantity: 198 devices Lot/code info: HEM1 UDI 00690103197006 (Serial No. 13800180, 13800185, 13800193, 13800195, 13800228, 13800162, 13800168, 13800171, 13800208, 13800210, 13800211, 13800126, 13800128, 13800129, 13800130, 13800132, 13800133, 13800135, 13800139, 13800140, 13800144, 13800146, 13800147, 13800148, 13800150, 13800187, 13800189, 13800131, 13800134, 13800136, 13800191, 13800192, 13800197, 13800172, 13800173, 13800159, 13800184, 13800188, 13800339, 13800355, 13800199, 13800200, 13800141, 13800249, 13800258, 13800259, 13800260, 13800263, 13800265, 13800268, 13800270, 13800176, 13800177, 13800179, 13800186, 13800225, 13800227, 13800230, 13800196, 13800124, 13800125, 13800137, 13800138, 13800142, 13800143, 13800145, 13800149, 13800151, 13800152); HEMSGM10 UDI 00690103196993 (Serial No. 13600223, 13600224, 13600225, 13600226, 13600257, 13600196, 13600197, 13600198, 13600227, 13600228, 13600229, 13600158, 13600159, 13600160, 13600161, 13600162, 13600163, 13600164, 13600165, 13600166, 13600167, 13600168, 13600169, 13600170, 13600171, 13600206, 13600207, 13600145, 13600146, 13600147, 13600208, 13600209, 13600211, 13600199, 13600201, 13600193, 13600194, 13600195, 13600390, 13600421, 13600212, 13600213, 13600202, 13600203, 13600204, 13600205, 13600255, 13600256, 13600258, 13600210, 13600148, 13600149, 13600150, 13600151 13600152, 13600153, 13600154, 13600155, 13600156, 13600157); HEMOXSC100 UDI 00690103196986 (Serial No. 13700241, 13700246, 13700247, 13700248, 13700303, 13700188, 13700189, 13700190, 13700280, 1
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.