Recall Z-2061-2017— Respironics California Inc
Class I · Terminated
Class I FDA medical device recall by Respironics California Inc, initiated 2017-04-24, terminated 2018-08-13. It names 2 FDA 510(k) clearances: K102985, K082660. 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, 989805616411, 989805636631.. Reason: 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 data travelling through the cable during the high resistance event..
- Recalling firm
- Respironics California Inc
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2017-04-24
- Terminated
- 2018-08-13
- Firm location
- Carlsbad, CA, United States
510(k) clearances named in this recall
2 on FDA's record- K102985 — V60 VENTILATOR WITH PPV AND AUTO-TRAK+ SOFTWARE OPTIONS
- K082660 — V60 VENTILATOR, MODEL V8000
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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, 989805616411, 989805636631.
Reason for recall
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 data travelling through the cable during the high resistance event.
Data sourced from openFDA. This site is unofficial and independent of the FDA.