Recall record at a glance
| Official record | Z-1622-2020 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Ongoing |
| Recalling firm | Respironics California, LLC |
| Report date | Apr 8, 2020 |
| Recall initiation date | Mar 5, 2020 |
| Quantity | 23581 |
| Location | Carlsbad, CA, United States |
Official product description
Philips V60 Ventilators with Power Management PCBA part number 1055906
Why the product was recalled
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
Distribution information
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
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
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