Z-1831-2021 Class II Terminated
FDA device recall Z-1831-2021 was initiated by Normand-Info S.A.S.U. on March 22, 2021 and is designated Class II. Reason for recall: Instructions For Use for software versions 1.5 to 1.9 did not provide sufficient instructions regarding the proper programming and testing of rules. Therefore, rules written by users that were not val… The recall status is terminated (terminated December 30, 2022). Affected quantity: 8,402 units with the affected software.
Recall Details
- Product Type
- Devices
- Report Date
- June 16, 2021
- Initiation Date
- March 22, 2021
- Termination Date
- December 30, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8,402 units with the affected software
Product Description
Reason for Recall
Distribution Pattern
Worldwide distribution - US Nationwide distribution in the states of Alabama, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Indiana, Iowa, Kansas, Louisiana, Maine, Maryland, Massachusetts, Michigan, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New York, Pennsylvania, Rhode Island, South Carolina, Texas, West Virginia and Wyoming. The countries of Australia, Austria, Belgium, Brunei, Canada, China, Colombia, Congo, Czech Republic, Denmark, Ethiopia, France, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Lithuania, Malaysia, Mayotte, Morocco, Netherlands, Netherlands Antillean, New Zealand, Norway, Poland, Portugal, Qatar, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Uganda, UAE, UK, and Zimbabwe.