Philips HeartStart MRx Processor Board Replacement Kits Recalled for Damaged Bags
Philips is recalling HeartStart MRx Processor Board PCA Replacement Kits because damaged ESD bags were used for storing components.
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 source text identifies the hazard as damaged ESD bags used for storage, which is a packaging and handling issue rather than a direct functional defect or reported injury. This aligns with the rubric for moderate severity involving packaging-only problems or minor labeling/storage errors.
Plain-English summary
Philips North America, LLC is recalling HeartStart MRx Processor Board PCA Replacement Kits (453563478461). These kits are components of the Philips HeartStart MRx Monitor/Defibrillator, which is intended for use in hospital and prehospital settings by qualified medical personnel.
The recall is due to damaged ESD (Electrostatic Discharge) bags used for storing components within the kits. The agency has classified this as a Class II recall. A total of 8 units were distributed, including 2 in the US and 6 outside the US. Distribution included the US states of Oklahoma and New York, as well as Libya, the Netherlands, Canada, South Africa, and the United Kingdom.
Affected serial numbers include CO1-1643IDOTDB, CO1-1639100N3T, C01-16391D0NB2, CO1-1639100N43, C01-1639100ND0, C01-16391D0N6N, C01-16391D0N4N, and C01-1&39IDON1J. Users should contact Philips North America, LLC for further instructions regarding the replacement or repair of these components.
The recalled product
- Product
- HeartStart MRx Processor Board PCA Replacement Kits 453563478461, a component of the Philips HeartStart MRx Monitorl/Defibrillator - Product Usage: is intended for use in hospital and prehospital settings by qualified medical personnel trained in the operation of the device and…
- Manufacturer
- Philips North America, LLC
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 (3)
- Serial Numbers: CO1-1643IDOTDB CO1-1639100N3T C01-16391D0NB2
- CO1-1639100N43 C01-1639100ND0 C01-16391D0N6N
- C01-16391D0N4N C01-1&39IDON1J
Distribution
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