Z-1622-2020 Class II Ongoing
FDA device recall Z-1622-2020 was initiated by Respironics California, LLC on March 5, 2020 and is designated Class II. 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… The recall status is ongoing. Affected quantity: 23581.
Recall Details
- Product Type
- Devices
- Report Date
- April 8, 2020
- Initiation Date
- March 5, 2020
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 23581
Product Description
Reason for Recall
Distribution Pattern
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