Getinge Recalls Seven PulsioFlex Monitoring Systems Due to Error Messages
Getinge US Sales LLC is recalling seven PulsioFlex Monitoring Systems because they display an internal error message requiring restart or service.
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 recall is classified as FDA Class II, and the hazard is a software error message without reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Getinge US Sales LLC is recalling seven units of the PulsioFlex Monitoring System, Model Number PC400 3 R0, Part Number 6882747. The recall involves specific serial numbers: K17400011005, K17400011065, K17400011082, K17400011086, K17400011097, K17400011107, and L17400011267. The affected software version is V5.1.0.7 US ver. A.
The recall was initiated because the monitors display an error message stating "internal error restart or service." The PulsioFlex Monitoring System is indicated for patients where cardiovascular and circulatory volume status monitoring is necessary, including in surgical, medical, and other hospital units.
The affected units were distributed nationwide in the states of Maryland, Oklahoma, New York, Florida, and South Carolina. Healthcare facilities should check their inventory for the specific serial numbers listed and contact Getinge US Sales LLC for instructions on how to proceed.
The recalled product
- Product
- PulsioFlex Monitoring System, Part Number: 6882747, Model Number: PC400 3 R0. Usage: The PulsioFlex Monitoring System is indicated in patients where cardiovascular and circulatory volume status monitoring is necessary. If a patient s biometric data are entered, the…
- Manufacturer
- GETINGE US SALES LLC
- Hazard
- Affected units
- 7
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 (8)
- software version:V5.1.0.7 US ver. A.
- Serial number affected: K17400011005
- K17400011065
- K17400011082
- K17400011086
- K17400011097
- K17400011107
- L17400011267.
Distribution
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