Philips Respironics V60 Ventilator recalled for potential gas pathway contamination
DRE Medical Group recalled 22 Philips Respironics V60 ventilators due to potential contamination in the gas pathway of retrofitted units. These devices may pose a serious health risk to patients.
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 an FDA Class II recall of a critical medical device (ventilator) with potential gas pathway contamination presenting a serious health risk. While no illnesses or injuries have been reported to date, the inherent hazard of contamination in an oxygen delivery device constitutes a significant risk of harm.
Plain-English summary
DRE Medical Group Inc is recalling 22 Philips Respironics V60 ventilators (Model Numbers R1053618 and R1076709). These are retrofitted devices that were imported with Japanese language labels and NIST oxygen gas fittings. The affected serial numbers are: 100043954, 100050078, 100052760, 100052848, 100054619, 100054626, 100055277, 100055557, 100058549, 100058566, 100058837, 100058995, 100060228, 100065373, 100069520, 100070487, 100071122, 100072691, 100078379, 100080232, 100080844, and 201003462.
The gas pathway of these devices may be contaminated, which poses a serious health risk. The Philips Respironics V60 Ventilator is intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen.
The recalled units were distributed in California and Florida. Consumers with these devices should contact DRE Medical Group Inc for further information regarding this recall.
The recalled product
- Product
- Philips Respironics V60 Ventilator-Intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Model Number: R1053618 and R1076709. These are retrofitted device.
- Manufacturer
- DRE Medical Group Inc
- Affected units
- 22
Distribution
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