Philips Respironics V60 Plus 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 respira
Check against the official notice below — it lists the full affected range.
Respironics California, LLC is recalling Philips Respironics V60 Plus Ventilators with Software Versions 3.00 and 3.10 that are equipped with High Flow Therapy. The ventilators have a safety mechanism designed to limit pressure delivery to patients. When system pressure reaches its maximum limit, the ventilator sounds a "Cannot Reach Target Flow" alarm and reduces both pressure and flow rate below the levels set by clinicians. If the underlying pressure issue is not resolved, the ventilator continues delivering this lower flow rate, which can cause patients to experience moderate or severe oxygen desaturation (hypoxemia).
A total of 23,115 V60/V60 Plus systems have been distributed worldwide, including across all U.S. states and numerous countries. The affected units can be identified by specific model numbers (P/N 1138747 and 1137276) and corresponding serial numbers and UDI codes listed in the recall documentation. The recall source does not specify a remedy or action for affected consumers.
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 Plus Ventilator: P/N 1138747 and 1137276; US System Serial Number/UDI Code: 100363973/ ; 100366525/ ; 100366542/ ; 100371876/ (01)00884838090996(21)100371876; 100373102/ (01)00884838090996(21)100373102; 100374459/ (01)00884838090996(21)100374459; 100376350/ (01)00884838090996(21)100376350; 100377311/ (01)00884838090996(21)100377311; 100377324/ (01)00884838090996(21)100377324; 100380441/ (01)00884838090996(21)100380441; 100382407/ (01)00884838090996(21)100382407; 100382452/ (01)00884838090996(21)100382452; 100382461/ (01)00884838090996(21)100382461; 100384413/ (01)00884838090996(21)100384413; 100384748/ (01)00884838090996(21)100384748; 100385425/ (01)00884838090996(21)100385425; 100385428/ (01)00884838090996(21)100385428; 100385429/ (01)00884838090996(21)100385429; 100385447/ (01)00884838090996(21)100385447; 100385529/ (01)00884838090996(21)100385529; 100386081/ (01)00884838090996(21)100386081; 100386137/ (01)00884838090996(21)100386137; 100386179/ (01)00884838090996(21)100386179; 100389986/ (01)00884838090996(21)100389986; 100390076/ (01)00884838090996(21)100390076; 100392652/ (01)00884838090996(21)100392652; 100392801/ (01)00884838090996(21)100392801; 100392809/ (01)00884838090996(21)100392809; 100392899/ (01)00884838090996(21)100392899; 100393482/ (01)00884838090996(21)100393482; 100393544/ (01)00884838090996(21)100393544; 100393555/ (01)00884838090996(21)100393555; 100393571/ (01)00884838090996(21)100393571; 100393741/ (01)00884838090996(21)100393741; 100393749/
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.