Z-1208-2018 Class II Terminated
FDA device recall Z-1208-2018 was initiated by Covidien LLC on November 21, 2017 and is designated Class II. Reason for recall: Rechargeable lithium-ion batteries with incorrect firmware that are used in certain Puritan Bennett 980 ventilators may not fully charge after installation. The recall status is terminated (terminated July 10, 2020). Affected quantity: 15,885.
Recall Details
- Product Type
- Devices
- Report Date
- April 4, 2018
- Initiation Date
- November 21, 2017
- Termination Date
- July 10, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 15,885
Product Description
Reason for Recall
Distribution Pattern
Worldwide Distribution - USA (nationwide) Distribution to the states of : AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV, WY, and the District of Columbia. and to the countries of : Argentina, Chile, Mexico, Panama, Canada, Australia, New Zealand, Austria, Bahrain, Belgium, Bulgaria, Croatia, Czech Republic, Egypt, Estonia, France, Germany, Greece, Hungary, Ireland, Italy, Jordan, Kuwait, Latvia, Lebanon, Lithuania, Morocco, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey, United Arab Emirates, United Kingdom, Israel, Netherlands, Tunisia, Brunei, Indonesia, Malaysia, Myanmar, Philippines, Singapore, Thailand, and Vietnam