—#179536

Product

Philips HeartStart FRx AED, Model 861304, FRx codeRev: E.02.017

FDA product code: MKJ — Automated External Defibrillators (Non-Wearable)
Device class: Class 3
Medical specialty: Cardiovascular
510(k) numbers: K020715, K040904, K050004
Affected lot / code info: 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

Why it was recalled

Affected devices contain a Printed Circuit Assembly (PCA) that was not manufactured/repaired in accordance to quality standards.

Root cause (FDA determination)

Process control

Action the firm took

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

Recalling firm

Firm: Philips North America LLC
Address: 22100 Bothell Everett Hwy, Bothell, Washington 98021-8431

Distribution

Distribution pattern: 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

Timeline

Recall initiated: 2019-09-10
Terminated: 2024-04-29
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #179536. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.