FDA Medical Device Recalls (openFDA)
Philips North America LLC: Philips HeartStart FRx AED, Model 861304, FRx codeRev: E.02.017
- Recall number
- Z-1271-2020
- Recalling firm
- Philips North America LLC
- Product
- Philips HeartStart FRx AED, Model 861304, FRx codeRev: E.02.017
- Status
- Terminated
- Initiated
- 2019-09-10
- Posted
- not on file
- Terminated
- 2024-04-29
- Reason
- Affected devices contain a Printed Circuit Assembly (PCA) that was not manufactured/repaired in accordance to quality standards.
- Root cause
- Process control
- Action
- On 09/11/2019, the firm sent an "Customer Information Medical Device Recall" notification to customers via Certified Mail informing them that certain models of their Automated External Defibrillator (AED) contain a Printed Circuit Assembly (PCA) manufactured by a supplier that did not follow specific procedures when repairing PCAs that initially failed required testing. After being repaired, these PCAs passed all testing at the supplier's facility prior to being assembled into AEDs. The Recalling Firm's quality standards require that the PCAs both be repaired according to specified procedures and pass testing. The Recalling Firm states that the serial number of the AED is printed on the label on the back of the device. The Recalling Firm will replace the affected devices at no charge and while awaiting for the replacement AED, the customer may continue to use the device. The Recalling Firm or distributors will contact customers to arrange for replacement and removal of affected devices. For any additional questions/information, consumers can contact the Recalling Firm at (800)263-3342 option 5 to speak with a AED Recall Team or email heaertstartaedaction@philips.com
- Quantity
- 44 units
- Distribution
- HeartStart FRx: US - CA, CT, FL, IL, MO, NY,TN, TX and WI OUS - Australia, Brazil, Canada, Germany, Italy, Japan, South Korea, Norway, Switzerland and Taiwan. HeartStart HS1: US - CT, FL, IL, MI, MS, NJ, TN, TX, WA and WI OUS - Argentina, Australia, Canada, France, Germany, Hong Kong, Italy, Japan, Netherlands, Norway, Spain, Sweden, and Taiwan
- Lot, serial or model codes
- Model: 861304 Software Version: FRx codeRev: E.02.017 System Serial Numbers: B17G-05063 B17C-03662 B17D-00167 B16G-06056 B16J-03182 B16J-03349 B14J-00603 B15E-08588 B15G-03528 B16A-00186 B16A-00189 B16A-00235 B16J-01934 B17G-02322 B17G-02937 B17I-00135 B18E-01082 B16L-03105 B15L-01146 B14H-00561 B17D-00056 B18E-01975 B16K-02837 B16E-01325 B16E-01627 B15E-06814 B15L-07200 B16K-03381 B13G-04020 B17F-02048 B17I-08789 B14I-00249 B15G-02703 B16E-01403 B16E-00725 B16F-04894 B16J-06377 B16G-05481 B16K-03980 B17F-07414 B17H-05164 B17I-07486 B16C-00187 B17D-00228
- 510(k) numbers
- ["K020715","K040904","K050004"]
- PMA numbers
- not on file
- Product code
- MKJ
- Firm FEI
- 1000524572
- Firm city
- Bothell
- Firm state
- WA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28