Device product
MicroScan autoSCAN-4 Instrument, Catalog Number B1018-280
Z-0269-2023
Product summary
- Event
- Event 90941
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 53 plates
- Official record key
device-enforcement:Z-0269-2023
Official wording
Reason: Due to MicroScan autoSCAN-4 Instruments being manufactured with an incorrect diffuser plate.
Code information: MicroScan autoSCAN-4 Instrument Catalog Number: B1018-280 UDI-DI Code: 15099590658625 Serial Numbers for new manufactured: 400495, 400496, 400497, 400498, 400499, 400500, 400503, 400504, 400506, 400507, 400508, 400509 400510, 400511, 400512, 400513, 400514, 400515, 400516, 400517, 400518, 400519, 400520, 400521 400522, 400523, 400524, 400528 Diffuser Plate component Part Number: P/N 5639-0001 Serial Numbers for previously install base: 6685, 6786, 6826, 7480, 8449, 9911, 10405, 10446, 10886, 11219, 11295, 11424, 11815, 11841, 20351, 20403, 300003, 300175, 400058, 400080, 400234, 400340, 400354, 400373, 400444
Distribution pattern: Worldwide - U.S. Nationwide distribution in the states of AK, FL, IA, ID, MI MS, MT, NC, NE, PA, SC, TX WA, WI, and WV. The countries of Chile, Germany, Indonesia, Italy, Japan, Mexico, Peru, Portugal, South Africa, Spain, United Kingdom of Great Britain and Northern Ireland, and Uruguay.
Derived failure modes
-
Unknown
Due to MicroScan autoSCAN-4 Instruments being manufactured with an incorrect diffuser plate.