Philips Respironics V60 Ventilator with Software Versions 3.00 and 3.10. The Respironics V60/V60 Plus Ventilator is an assist ventilator and is intended to augment patient breathing. It is intended for spontaneously breathing individuals who require mechanical ventilation: patients with respiratory
Check against the official notice below — it lists the full affected range.
Philips Respironics is recalling 23,115 Respironics V60 and V60 Plus ventilators with High Flow Therapy software versions 3.00 and 3.10 that were distributed nationwide in the U.S. and internationally. The ventilators have a safety mechanism designed to limit pressure delivery, but when system pressure reaches its maximum limit, the device triggers a "Cannot Reach Target Flow" alarm and reduces both the pressure and the flow rate below the levels set by clinicians. If the underlying pressure issue is not resolved, the ventilator continues supplying the reduced flow rate, which can cause patients to experience moderate to severe oxygen desaturation (low blood oxygen levels).
The recall affects ventilators with multiple part numbers and serial numbers/UDI codes distributed across all U.S. states and numerous countries worldwide. The source document does not specify what actions affected consumers should take in response to this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
It has been identified that ventilators equipped with High Flow Therapy (Software Versions 3.00 and 3.10), that includes a designed safety mechanism that limits the amount of pressure that can be delivered to a patient, in situations where the system pressure reaches the maximum limit and sounds the "Cannot Reach Target Flow" alarm , the system will reduce pressure and simultaneously decreasing the flow rate to a level below what was set by the clinicians. If the reason for the increase in pressure is not resolved, the ventilator will continue to provide the lower flow rate, which result in patients experiencing oxygen desaturation which can be characterized as moderate or severe hypoxemia.
Reason for recall: It has been identified that ventilators equipped with High Flow Therapy (Software Versions 3.00 and 3.10), that includes a designed safety mechanism that limits the amount of pressure that can be delivered to a patient, in situations where the system pressure reaches the maximum limit and sounds the "Cannot Reach Target Flow" alarm , the system will reduce pressure and simultaneously decreasing the flow rate to a level below what was set by the clinicians. If the reason for the increase in pressure is not resolved, the ventilator will continue to provide the lower flow rate, which result in patients experiencing oxygen desaturation which can be characterized as moderate or severe hypoxemia. Distribution: Worldwide Distribution: U.S (nationwide) to states of.: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SC, TN, TX, UT, VA, VT, WA, WI, WV, and WY; and O.U.S. countries of: Andorra, United Arab Emirates, Albania, Argentina, Austria, Australia, Belgium, Canada, Switzerland, Chile, China, Colo Quantity: Total of V60/V60 Plus = 23,115 systems Lot/code info: Model V60 Ventilator: P/N 1053613, 1053614, 1053615, 1053616, 1053617, DU1053617, U1053617, 1076716, 1137292 US System Serial Number/UDI Code: 100351272 (01)00884838020054(21)100351272 100006691 100193211 100220566 (01)00884838020054(21)100220566 100313757 (01)00884838020054(21)100313757 100313412 (01)00884838020054(21)100313412 100080135 100081569 100110187 100121703 100013472 100230650 (01)00884838020054(21)100230650 100374411 (01)00884838020054(21)100374411 100054305 100068863 100188390 100181283 100030036 100030039 100030046 100030040 100043349 100030041 100037246 201029401 (01)00884838020054(21)201029401 100278366 (01)00884838020054(21)100278366 100088340 100131320 201030489 (01)00884838020054(21)201030489 100057026 100074563 201005638 201001514 100027860 201005635 100154662 100056752 100130449 100154846 100078004 100055123 100191452 100077709 100015080 100191788 100129710 100028046 100077079 201017909 100224361 (01)00884838020054(21)100224361 100043830 100024302 100133355 100077493 100077503 100039424 100177846 201011206 100076877 100191271 100152171 100056385 100120289 100262177 (01)00884838020054(21)100262177 100120262 100047561 100156074 100104165 100115189 201026331 (01)00884838020054(21)201026331 100057549 100133002 100258925 (01)00884838020054(21)100258925 201030702 (01)00884838020054(21)201030702 100040748 100290605 (01)00884838020054(21)100290605 100044617 100147649 100038426 100049697 100318142 (01)00884838020054(21)100318142 100062636 100047178 100130954 10001
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.