LIFEPAK 15 Monitor/Defibrillator Recalled Due to Manufacturing Tool Defect
Physio-Control is recalling 105 LIFEPAK 15 monitor/defibrillator systems due to a manufacturing defect caused by an out-of-tolerance tool used during assembly. Affected units were distributed in Connecticut, Georgia, Massachusetts, New York, Ohio, Washington, and West Virginia.
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: This is a Class II recall with no reported injuries or illnesses. The manufacturing defect affects a critical medical device where potential for patient harm exists but has not been documented, meeting the High severity criterion for risk-of-harm products without reported injury.
Plain-English summary
Physio-Control, Inc. is recalling 105 LIFEPAK 15 (LP15) monitor/defibrillator systems due to a manufacturing defect. During assembly, an out-of-tolerance tool was used in the production of these devices.
The LIFEPAK 15 is a cardiac monitor and defibrillator used in healthcare facilities and emergency medical services. The affected units were distributed in the United States across Connecticut, Georgia, Massachusetts, New York, Ohio, Washington, and West Virginia.
Healthcare organizations and emergency services should verify whether they have affected equipment by referencing the specific model numbers and serial numbers identified in this recall. Contact Physio-Control for corrective actions and instructions on device replacement or repair.
The recalled product
- Product
- LIFEPAK 15 (LP15) Model/Catalog Numbers: o 97577-000101 o 99577-000046 o 99577-000055 o 99577-000061 o 99577-000076 o 99577-001250 o 99577-001255 o 99577-001256 o 99577-001368 o 99577-001955 o 99577-001956 o 99577-001957 o 99577-001958 o 99577-001962 LIFEPAK 15…
- Manufacturer
- Physio-Control, Inc.
- Hazard
- Affected units
- 105
Distribution
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