International safety notice
In some lots of ILS 0914-12 and ILS-0914-20 for use with ATEC handpieces in MRI-guided biopsies, The manufacturer has confirmed that the brown cap on the distal end of the loducer sheath can become dislodged during a biopsy. Therefore, we decided to carry out a voluntary recall.
Japan / PMDA Recalls · JPN · Oct 4, 2022
Key facts
| Title | In some lots of ILS 0914-12 and ILS-0914-20 for use with ATEC handpieces in MRI-guided biopsies, The manufacturer has confirmed that the brown cap on the distal end of the loducer sheath can become dislodged during a biopsy. Therefore, we decided to carry out a voluntary recall. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | General name: Suction-type tissue production needle キット Brand name: ATEC Breast Biopsy System |
| Manufacturer | Hologic Japan Co., Ltd. |
| Models | 21G20RS, 0914-20, 21G12RA, 0914-12 |
| Date | Oct 4, 2022 |
| Regulator page | info.pmda.go.jp |
At a glance
- No Recall
- No Field safety notice
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About International device safety notices
Field safety notices, recalls and safety alerts published by about 30 national medical device regulators outside the United States, matched by Orca1 to FDA device data.
Source: National medical device regulators (as listed), compiled by Orca1