Class 2 Device Recall Philips V60 Ventilator

• Date Initiated by Firm: March 05, 2020
• Create Date: March 31, 2020
• Recall Status: Open, Classified
• Recall Number: Z-1622-2020
• Recall Event ID: 85113
• 510(K)Number: K082660
• Product Classification: Ventilator, continuous, minimal ventilatory support, facility use - Product Code MNT
• Product: Philips V60 Ventilators with Power Management PCBA part number 1055906
• Code Information: Serial Numbers: 100002908 to 100027093; 100027096 to 100085389; 100085399 to 100109746; 100109868 to 201003390; 201003392 to 201010952
• Recalling Firm/ Manufacturer: Respironics California, LLC; 2271 Cosmos Ct; Carlsbad CA 92011-1517
• For Additional Information Contact: Philips Customer Services; 800-722-9377
• Manufacturer Reason for Recall: Solder connection failure on Power Management printed circuit board assembly of ventilators may cause 1) Blower to lose power, spool down, and trigger visual and audible High Priority Check Vent alarm indicating a need for alternative ventilation, or 2) Intermittent connection may disrupt expected operation and trigger unexpected shutdown without alarm. Failures may lead to hypercarbia/hypoxemia
• FDA Determined Cause: Under Investigation by firm
• Action: On 03/05/20 Urgent Medical Device Correction Field Safety Notices were mailed to customers. Customers were informed that it is not necessary to remove affected V60 ventilators from service due to the rarity of these failure modes. Customers were asked to do the following: From the Operator's Manual: 1. Use an external O2 monitor/analyzer and set the ventilator alarm thresholds appropriately. 2. Promptly attend to all alarms presented by the ventilator. 3. Ensure that an alternative means of ventilation is available whenever the ventilator is in use. Additional directions: 4. Follow the above procedure to determine whether the V60 ventilator is affected by this correction without interrupting therapy. 5. If a V60 ventilator experiences a shutdown, disconnect the patient and immediately start ventilation with an alternate device. Contact a local customer service contact to report the failure and to schedule corrective maintenance. 6. Acknowledge receipt of this notification by fax or e-mail. The firm notified customers that once Power Management PCBAs are available, you will be contacted by your approved service provider to schedule a corrective maintenance to replace the Power Management PCBA at a time when the ventilator will not be in use. In addition, customers were asked to review the information with all staff members who need to be aware of the contents of the communication. Retain a copy of this notice and include with the equipment Instructions for Use. Distributors were informed: It is imperative that all end-users with affected Ventilators listed in the "AFFECTED PRODUCTS" section of this FSN, receive this Medical Device Correction notice. Because the firm sells these products through distributors, including your organization, we may not have the information to contact all users. Therefore, send a copy of the attached Field Safety Notice to any customer to whom you have distributed one of the affected devices. Note: the firm has sen
• Quantity in Commerce: 23581
• Distribution: U.S.: CO, PA, AZ, OH, MT, AR, FL, NC, KS, IL, CA, HI, MD, SC, WY, OR, NY, NE, OK, MN, UT, ND, LA, IN, AL, AK, WV, GA, WI, MI, VA, NJ, TX, WA, SD, KY, TN, MS, MO, DE, MA, VT, CT, IA, NV, ID, ME, NM, DC, NH, VI, RI, PR. O.U.S.: Argentina, Australia, Austria, Bahrain, Belgium, Bolivia, Brazil, Canada, Chile, China, Croatia, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, Germany, Gibraltar, Hong Kong, Iceland, India, Indonesia, Iran, Ireland, Israel, Italy, Jersey, Kazakhstan, Kenya, Korea, Republic of, Kosovo, Kuwait, Lebanon, Libya, Luxembourg, Malaysia, Maldives, Malta, Mexico, Morocco, Namibia, Netherlands, New Zealand, Nigeria, Norway, Oman, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Venezuela, Viet Nam
• 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.

• 510(K) Database: 510(K)s with Product Code = MNT and Original Applicant = RESPIRONICS CALIFORNIA, INC.