Merge Healthcare Recalls Schiller CO2 Sensors Due to Alarm Bias
Merge Healthcare is recalling 23 Schiller CO2 sensors that may display false clogging alarms, potentially adding bias to CO2 measurements and affecting alarm notifications.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device where a defect could affect CO2 measurement accuracy and alarm notifications, posing a risk of harm to patients, although no specific injuries or illnesses are reported in the source text.
Plain-English summary
Merge Healthcare, Inc. is recalling 23 Schiller AG ISA CO2 Sensors (also known as PhaseIn Units), Part Number HW-HEMO-00001. These sensors are optional accessories sold separately for the Merge Hemo Patient Data Module (PDM), which is a component of the Merge Hemo system.
The recall is due to a defect where the units may display a "sampling line clogged" alarm after the automatic flow zeroing procedure that occurs one hour after startup. This issue could result in a small bias being added to the CO2 measurement and may affect the alarm notification.
The affected sensors were distributed to medical facilities in Alabama, Florida, Idaho, Louisiana, Missouri, North Carolina, Oklahoma, South Carolina, Texas, and Utah. There was government distribution, but no foreign or military distribution. The specific serial numbers for the recalled units are: 107349, 107357, 107358, 107363, 107370, 107377, 107390, 107407, 107435, 107476, 107509, 107510, 107556, 107659, 107700, 107707, 107768, 107776, 107831, 107832, 107836, 107839, and 107841. Medical facilities should check their inventory for these serial numbers and contact Merge Healthcare for instructions on returning the units.
The recalled product
- Product
- Schiller AG ISA CO2 Sensor (AKA: PhaseIn Unit), Merge Part Number HW-HEMO-00001. The PhaseIn Unit is an optional accessory (sold separately) to the Merge Hemo Patient Data Module (PDM). The PDM is a major component of the Merge Hemo system.
- Manufacturer
- Merge Healthcare, Inc.
- Affected units
- 23
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)
- ISA CO2 Sensor serial numbers: 107349
- 107357
- 107358
- 107363
- 107370
- 107377
- 107390
- 107407
- 107435
- 107476
- 107509
- 107510
- 107556
- 107659
- 107700
- 107707
- 107768
- 107776
- 107831
- 107832
Distribution
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