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.
What this means for you
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 hemodynamic
- Manufacturer
- Edwards Lifesciences, LLC
- Hazard
- 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
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