Generic Name: Automated External Defibrillator For Non-medical Personnel — Trade Name: Rescue Heart Hdf-3500 Automated External Defibrillator
Recall Summary Omron Healthcare is recalling certain Rescue Heart HDF-3500 Automated External Defibrillators (AEDs) due to a potential manufacturing defect that could prevent the device from delivering an electric shock when needed. The issue stems from modifications made to comply with European environmental regulations and affects multiple production lots from 2023. Although no failures have occurred in actual use and the defect rate is extremely low, the company is recalling the devices out of caution.
- Recalling firm
- Name of Manufacturer and Distributor: Omron Healthcare Co., Ltd. — Address of Manufacturer and Distributor: 53 Kuno-tsubo, Terado-cho, Muko City, Kyoto Prefecture — Type of License: Class I...
- Product
- Lot: 製造番号 ： 23H90004221、23H90004525、23H90004582、23H90004807、23H90004843〜23H90004865 23H90004867〜23H90004905、23H90004907〜23H90004924、23H90004926〜23H90004942 23H90004944、23H90004958、23H90004974、23H90004977、23H90005147〜23H90005197 23H90005199〜23H90005305、23H90005307〜23H90005455、23H90005457〜23H90005486 23H90005488、23H90005490〜23H90005496、23H90005498〜23H90005539 23H90005541〜23H90005550、23H90005552〜23H90005724、23H90005727〜23H90005742 23H90005744〜23H90005780、23H90005782〜23H90005798、23H90005816 23H90005937〜23H90005977、23H90005979〜23H90006024、23H90006026〜23H90006027...
- Reason
- This product is an automated external defibrillator (AED) designed for use by laypeople to perform defibrillation on patients experiencing sudden cardiac arrest by delivering an electric shock through adhesive electrode pads. Extensive quality testing by the manufacturer has confirmed that modifications made to the manufacturing process to comply with European environmental regulations (RoHS) may cause malfunctions in the printed circuit board components inside the unit, potentially resulting in the device being unable to deliver an electric shock. Although the incidence rate confirmed in...
- Classification
- Class I
- Category
- medical device recall
- Country
- Japan
- Agency
- PMDA-DEVICE
- Status
- Ongoing
Official recall notice from PMDA-DEVICE
Recall details on Nibble Recalls: https://trynibble.app/recalls/0ea2edff-4973-4c60-8125-5ca8407d8f37