Generic Name: Program For General-purpose Diagnostic Imaging Workstations Trade Name: Medical Imaging Workstation Caps
- Recalling firm
- Name of manufacturer and seller: 3Z Corporation Location of manufacturer and seller: NCO Kanda Konyacho 5F, 8 Kanda Konyacho, Chiyoda-ku, Tokyo Type of license: Type II medical device manufacturer...
- Product
- Lot: 製造番号： 3ZP05323247,3ZP05384498,3ZP05385264,3ZP05395961,3ZP05417012,3ZP05418099,3ZP05419559,3ZP05420307, 3ZP05421635,3ZP05422742,3ZP05423747,3ZP05424062,3ZP05425601,3ZP05426404,3ZP05427492,3ZP05428230, 3ZP05429721,3ZP05430081,3ZP05483066,3ZP05484238,3ZP05485857,3ZP05486886,3ZP05487710,3ZP05490841, 3ZP05491782,3ZP05492338,3ZP05493731,3ZP05494743,3ZP05495150,3ZP05496236,3ZP05497321,3ZP05498158, 3ZP05499649,3ZP05500083,3ZP05501210,3ZP05502208,3ZP05503926,3ZP05504420,3ZP05505810,3ZP05506273, 3ZP05507011,3ZP05508200,3ZP05509687,3ZP05510781,3ZP05511640,3ZP05512220,3ZP05513509,3ZP05514460,...
- Reason
- It was found that the address of the manufacturer and seller, which is legally required to be indicated on the labeling of the product in question, was not listed.
- Classification
- Class III
- Category
- medical device recall
- Country
- Japan
- Agency
- PMDA-DEVICE
- Recall date
- 2026-02-26
- Status
- Ongoing
Official recall notice from PMDA-DEVICE
Recall details on Nibble Recalls: https://trynibble.app/recalls/d8cb7be9-2192-4f21-8557-e0acd0b7d6f2