LIFEPAK 15 Monitor Software Error Disables Sensor Monitoring
Physio-Control is recalling 622 LIFEPAK 15 V4 monitors due to a software error that prevents monitoring of carboxyhemoglobin and methemoglobin saturation levels in affected sensors.
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 3/5 (High).
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: FDA Class II device with a software error that disables critical monitoring capabilities. The disabled sensors detect serious poisoning and metabolic conditions; while no injuries have been reported, the error creates risk of harm in affected healthcare settings where these monitoring parameters may be clinically necessary.
Plain-English summary
Physio-Control, Inc. is recalling 622 LIFEPAK 15 V4 monitor/defibrillator units with Masimo Rainbow Sensors. The recall addresses a software error message that prevents users from utilizing carboxyhemoglobin saturation (SpCO) and methemoglobin saturation (SpMet) monitoring sensors.
The affected devices include adult adhesive sensors (catalog 11996-000515, lot 23G79), adult reusable sensors (catalog 11996-000519, lots 23HER, 23HPT, 23JBN, 23JTA), and pediatric reusable sensors (catalog 11996-000520, lots 23HNV, 23JBP).
The devices have been distributed nationwide to healthcare facilities and emergency medical services across 28 states: California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Iowa, Kentucky, Massachusetts, Maryland, Michigan, Missouri, Mississippi, North Carolina, New Hampshire, New York, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington, Wisconsin, and West Virginia.
The recalled product
- Product
- LIFEPAK 15 V4/Masimo Rainbow Sensors: Masimo¿ RD rainbow Adt 8¿ SpCO, SpO2, and SpMet, Adult Adhesive Sensors REF 11996-000515 Masimo¿ LNCS-II rainbow¿ DCI 8¿ SpCO, Adult Reusable Sensor REF 11996-000519 Masimo¿ LNCS-II rainbow¿ DCI 8¿ SpCO, Pediatric Reusable Sensor…
- Manufacturer
- Physio-Control, Inc.
- Affected units
- 622
Distribution
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