International safety notice
Software version 1.1.0. 1: The measurement tool has a maximum error of 14%. 2: If there is a partial space in the puncture window of the compression plate, problems may occur in image processing. These issues do not affect the safety or effectiveness of the system, but the bugs have been fixed in Software 1.1.3. We will carry out a voluntary renovation to introduce 0.
Japan / PMDA Recalls · JPN · Nov 14, 2022
Key facts
| Title | Software version 1.1.0. 1: The measurement tool has a maximum error of 14%. 2: If there is a partial space in the puncture window of the compression plate, problems may occur in image processing. These issues do not affect the safety or effectiveness of the system, but the bugs have been fixed in Software 1.1.3. We will carry out a voluntary renovation to introduce 0. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Stationary digital breast X-ray diagnostic device Brand name: Affirm Prone Biopsy System |
| Manufacturer | Hologic Japan Co., Ltd. |
| Models | APB1100982, APB1100894, APB1100829, APB1100880, APB1101002, APB1100914, APB1100946, APB1100942, 100956, APB1100907, APB1101003, APB1101006 and 2 more |
| Date | Nov 14, 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