International safety notice
As a result of product analysis by the overseas manufacturer, the characteristics of defibrillation pad pack HDF-PD-3150 (hereinafter referred to as pad pack) In certain lots, battery cells that were in contact with the welded part due to defective spot welding of the installed battery. Because it was discovered that short circuits could occur in batteries, leakage current could prematurely drain the battery over time. We have decided to carry out a voluntary recall to replace the pack.
Japan / PMDA Recalls · JPN · Jun 2, 2023
Key facts
| Title | As a result of product analysis by the overseas manufacturer, the characteristics of defibrillation pad pack HDF-PD-3150 (hereinafter referred to as pad pack) In certain lots, battery cells that were in contact with the welded part due to defective spot welding of the installed battery. Because it was discovered that short circuits could occur in batteries, leakage current could prematurely drain the battery over time. We have decided to carry out a voluntary recall to replace the pack. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Automatic defibrillator for non-medical personnel Brand name: Components of "Automated External Defibrillator Rescue Heart HDF-3500" Defibrillation Pad Pack HDF-PD-3150 |
| Manufacturer | OMRON Healthcare Co., Ltd. |
| Models | C0331, HDF-PD-3150, C0329, C0245, C0283, C0335, C0333, C0250, C0247, C0286, C0330, C0248 and 13 more |
| Date | Jun 2, 2023 |
| Regulator page | info.pmda.go.jp |
At a glance
- No Recall
- No Field safety notice
- 1–9 Matching catalog numbers in FDA data
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