FDA Device recall Z-0496-2018

Hemosphere System with the following three components: HEM1 Advanced Monitor, HEMSGM10 (Swan-Ganz Module), and HEMOXSC100 (Oximetry Smart C…

FDA Device
Class II
terminated
Published 2018-02-07

On 2018-02-07 the FDA classified a Class II recall of Hemosphere System with the following three components: HEM1 Advanced Monitor, HEMSGM10 (Swan-Ganz Module), and HEMOXSC100 (Oximetry Smart C… by Edwards Lifesciences, citing pre-procedural issues related to software defects.

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-0496-2018
Classification	Class II
Status	terminated
Initiated	2017-10-02
Published	2018-02-07
Last updated	2026-09-13 11:54 UTC
Company	Edwards Lifesciences
Distribution	US

Product

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 module and/or cable and accompanying Edwards accessories and/or disposables. It provides Edwards hemodynamic monitoring technologies through modular connections. The HemoSphere Swan-Ganz Module (HEMSGM10) is intended to be used by qualified personnel or trained clinicians in a critical care environment in a hospital setting. It is a multi-use device that works in conjunction with the HemoSphere Advanced Monitor, patient CCO cable and compatible Swan-Ganz catheter to acquire and process temperature data supporting intermittent cardiac output (iCO), continuous cardiac output (CCO) and right ventricular end diastolic volume (EDV) monitoring. The HemoSphere Oximetry Smart Cable (HEMOXSC100) is intended to be used by qualified personnel or trained clinicians in a critical care environment in a hospital setting. It is a multi-use device that connects with a compatible Edwards monitor on one end and any approved Edwards oximetry catheter on the other end to continuously measure venous oxygen saturation by reflectance spectrophotometry. LEDs within the oximetry cable transmit light fiber optically to the distal end of the catheter. The amount of light absorbed, refracted, and reflected depends on the relative amounts of oxygenated and deoxygenated hemoglobin in the blood. This optical intensity data is gathered by the oximetry catheter, processed by the HemoSphere Oximetry Cable, and displayed on a compatible monitoring platform. Parameter output is mixed venous oxygen saturation (SvO2) or central venous oxygen saturation (ScvO2).

Reason

Pre-procedural issues related to software defects

Identifiers

code_info	HEM1 UDI 00690103197006 (Serial No. 13800180, 13800185, 13800193, 13800195, 13800228, 13800162, 13800168, 13800171, 138… 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, 1

code_info

HEM1 UDI 00690103197006 (Serial No. 13800180, 13800185, 13800193, 13800195, 13800228, 13800162, 13800168, 13800171, 138…

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, 1

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0496-2018%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.