Agency classClass IOur severity:Severe FDA (Devices)·Z-2061-2017·Announced 2017-05-24

Philips V60 Ventilators Recalled for Connector Pin Displacement

Respironics is recalling 30,516 Philips V60 Ventilators because low-frequency vibrations can displace connector pins, causing momentary data transmission failures.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Over time, low-frequency vibrations can cause the pins within the female connectors on the Motor Controller to Data Acquisition Board ribbon cable to become partially displaced causing momentary high resistance that prevents or restricts…"

Plain-English summary

Respironics California Inc is recalling 30,516 units of the Philips V60 Ventilator. The recall covers specific material numbers and serial numbers distributed worldwide, including the United States and numerous international markets.

The recall is due to a defect where low-frequency vibrations can cause pins within the female connectors on the Motor Controller to Data Acquisition Board ribbon cable to become partially displaced. This displacement creates momentary high resistance, which prevents or restricts data from traveling through the cable during the event.

The source text does not specify reported injuries, illnesses, or deaths associated with this defect. Consumers and healthcare providers should check their device serial numbers against the provided list and contact the manufacturer for further instructions.

The recalled product

Product: Philips V60 Ventilators, Material No. 850008, 1053613, 1053614, 1053615, 1053616, 1053617, 1076715, 1076716, 1076717, DU1053617, U1053617. Old Material No. 850008, 989805628251, 989805612101, 989805613391, 989805613661, 989805611761, 989805627411, 989805627431, 989805627441…
Manufacturer: Respironics California Inc
Category: Medical Device — Ventilator
Hazard: electrical-fault
data-transmission-failure
Affected units: 30,516

Distribution

Distributed nationwide across the United States.

Same manufacturer · Respironics California Inc

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Same hazard · electrical fault