Class 1 Device Recall Philips Respironics V60 Ventilator

• Date Initiated by Firm: June 18, 2021
• Create Date: July 22, 2021
• Recall Status: Open, Classified
• Recall Number: Z-2073-2021
• Recall Event ID: 88127
• Product Classification: Ventilator, continuous, minimal ventilatory support, facility use - Product Code MNT
• Product: 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 failure, chronic respiratory insufficiency, or obstructive sleep apnea in a hospital or other institutional settings under the direction of a physician.
• Code Information: 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 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• Recalling Firm/ Manufacturer: Respironics California, LLC; 2271 Cosmos Ct; Carlsbad CA 92011-1517
• For Additional Information Contact: David McGrath; 442-224-6650
• Manufacturer 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.
• FDA Determined Cause: Device Design
• Action: On 06/18/2021, the Recalling Firm sent an "URGENT - Medical Device Recall" Notification Letter via USPS certified mail to customers informing them that a problem has been detected in their ventilators that could pose a risk to patients or users. All units with High Flow Therapy option (Software Versions 3.00 and 3.10) are impacted. These ventilators with the High Flow Therapy software were designed with a safety mechanism to limit the amount of pressure that can be delivered to the patient when the ventilator is operating in High Flow Therapy. In situations where the high flow therapy pressure reaches the maximum limit, the ventilator will sound a low priority "Cannot Reach Target Flow (CRTF) alarm and reduces the pressure which also simultaneously decreases the flow rate to a level below what was set by the clinician for as long as the condition persists. Customers are instructed/informed to: When administering HFT via High Flow Nasal Cannula the following action must be taken: (1) Monitor the patients SpO2 continuously; (2) All patients that are dependent on supplemental oxygen, and at risk of clinical deterioration should be under constant and close monitoring by the clinician to prevent dangerous drops in blood oxygen levels, work of breathing and respiratory distress and resulting escalation in medical treatment (3) Respond to all alarms urgently, regardless of alarm priority; (4) If the patient cannot be constantly and closely monitored by the clinician, do not use High Flow Therapy. In addition; (5) Refer to and follow the attached user manual addendum titled V60 Plus User Manual Addendum: High-Flow Therapy Safety and Alarm Features . This user manual addendum provides additional technical details about the CRTF alarm functionality. The addendum is also available at www.philips.com/hrcmanuals under the V60/V60 Plus link titled "V60 Plus User Manual Addendum - High-Flow Therapy Safety and Alarm Features . For additional information and educ
• Quantity in Commerce: Total of V60/V60 Plus = 23,115 systems
• 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, Colombia, Czech Republic, Germany, Denmark, Spain, Finland, France, United Kingdom, French Guiana, Guadeloupe, Greece, Hong Kong, Indonesia, Ireland, India, Iceland, Italy, Jordan, Kenya, Kuwait, Lebanon, Latvia, Libya, Morocco, Martinique, Malta, Mexico, Malaysia, New Caledonia, Nigeria, Netherlands, Norway, New Zealand, Philippines, Poland, Portugal, Qatar, R¿union, Russian Federation, Saudi Arabia, Sweden, Singapore, Slovenia, Thailand, and South Africa.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.