—#179537

Product

Philips HeartStart HS1 Onsite (Model M5066A) and HSI Home (Model M5068A) AED, Model 861304, HSI codeRev: E.03.063

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: HeartSmart HS1 Onsite Model: M5066A Software Version: FRx codeRev: E.03.063 System Serial Numbers: A18B-01564 A18B-05110 A15F-00203 A15F-00836 A16A-05193 A18B-01898 A18B-04580 A18C-06368 A18C-13087 A14J-05349 A17G-04454 A16F-05540 A16H-00179 A16I-05335 A15C-06311 A18B-01163 A14E-01309 A14H-00385 A14H-03858 A14J-06953 A15B-02135 A15I-00313 A15J-02119 A15J-03499 A16A-00020 A16A-04110 A16D-02839 A16E-00092 A16E-00321 A16E-01139 A16H-01715 A16H-03269 A16H-03289 A16H-03295 A16H-03388 A16I-01108 A16I-01192 A16J-03827 A16K-09220 A16K-09284 A16K-09350 A16L-08039 A17D-02967 A17E-06623 A17L-05540 A18B-06555 A16B-01360 A16J-04476 A16F-05541 A16K-06215 A17F-05535 A17G-01106 A18B-05091 A16L-03891 A18D-00634 A14I-05831 A14I-06556 A14J-04548 A15H-01226 A15H-04421 A16B-05332 A16E-01367 A16F-01716 A16H-01397 A16H-02511 A16I-01557 A16I-01570 A16I-01572 A16I-01819 A16I-01992 A16I-02579 A16I-03774 A16I-08781 A16I-09247 A16I-09253 A16I-09345 A16K-02763 A17F-01602 A17F-02212 A17F-07151 A17I-06611 A17K-05176 A17L-12513 A17L-13149 A17L-13954 A17L-14968 A18A-00046 A18B-12050 A18C-12844 A18C-13301 A18C-13490 A18C-15686 A18C-16215 A18C-16221 A18C-16224 A18C-16236

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 #179537. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.