Z-1271-2020Class II

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

Name: Z-1271-2020 Philips HeartStart FRx AED, Model 861304, FRx codeRev: E.02.017
Creator: Philips North America LLC
Published: 2019-09-10
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2019-09-10 / Terminated / root cause: manufacturing process

FDA source

Philips North America LLC began a recall of Philips HeartStart FRx AED, Model 861304, FRx codeRev: E.02.017 on 2019-09-10. FDA classified it as Class II and gives the reason as "Affected devices contain a Printed Circuit Assembly (PCA) that was not manufactured/repaired in accordance to quality standards". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1271-2020
Classification: Class II
Status: Terminated
Initiated: 2019-09-10
Posted: 2020-02-19
Terminated: 2024-04-29
Recalling firm: Philips North America LLC
Product: Philips HeartStart FRx AED, Model 861304, FRx codeRev: E.02.017
Product code: MKJ Automated External Defibrillators (Non-Wearable)
Reason for recall: Affected devices contain a Printed Circuit Assembly (PCA) that was not manufactured/repaired in accordance to quality standards.
Root cause tag: manufacturing process
FDA 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 [email protected]
Quantity in commerce: 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
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1271-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1271-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-26	2020-02-19
Z-1272-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-26	2020-02-19

Product code MKJ

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)