Device product
Phoenix AST-s Indicator, Catalog Number 246009
Z-0933-2019
Product summary
- Event
- Event 81952
- Status
- Terminated
- Classification
- Class II
- Quantity
- 62880 total
- Official record key
device-enforcement:Z-0933-2019
Official wording
Reason: Panels inoculated using certain lots of the indicator solution are demonstrating an increased occurrence of test aborts.
Code information: Batch Numbers 8298797 8254819 8254817 8247760 8247750 8206530 8194853 8156642 8156638 8131658 8103973 8094595 8023542 7354942 7300813
Distribution pattern: The products were distributed to the following US states: AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, and WY. The products were distributed to the following foreign countries: Argentina, Australia, Bangladesh, Belgium, Brazil, Canada, Cayman Islands, Chile, China, Columbia, Costa Rica, Dominican Republic, Ecuador, Guatemala, India, Indonesia, Japan, Korea, Malaysia, Mexico, Myanmar, New Zealand, Pakistan, Panama, Peru, Philippines, San Salvador, Singapore, Sri Lanka, Thailand, Taiwan, Uruguay, Vietnam
Derived failure modes
-
Unknown
Panels inoculated using certain lots of the indicator solution are demonstrating an increased occurrence of test aborts.