Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0496-2018·Announced 2018-02-07

Edwards HemoSphere System Recalled for Pre-Procedural Software Defects

Edwards Lifesciences is recalling 198 HemoSphere System devices due to pre-procedural software defects. The devices are distributed in 11 US states.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Edwards Lifesciences, LLC is recalling 198 HemoSphere System devices, which include the HEM1 Advanced Monitor, HEMSGM10 (Swan-Ganz Module), and HEMOXSC100 (Oximetry Smart Cable). The recall is due to pre-procedural issues related to software defects. These devices are intended for use in critical care environments to monitor hemodynamic parameters and oxygen saturation.

The affected devices were distributed nationwide in the states of Arizona, California, Colorado, Georgia, Illinois, Missouri, New Mexico, Oklahoma, Oregon, South Carolina, and Texas. Specific serial numbers for the HEM1, HEMSGM10, and HEMOXSC100 components are listed in the official recall documentation.

Healthcare facilities and users should check their inventory for the specific serial numbers associated with this recall. The source text does not provide specific instructions for consumers or patients, as these are professional medical devices used by qualified personnel in hospital settings.

The recalled product

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…
Manufacturer: Edwards Lifesciences, LLC
Category: Medical Device — Hemodynamic Monitoring
Hazard: software-defect
Affected units: 198

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

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

Distribution

Distributed nationwide across the United States.

The notice also names 11 states specifically:

Same manufacturer · Edwards Lifesciences, LLC

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