CLASS II Device recall · Reported 30 May 2018 · FDA Enforcement Report

Philips HeartStart (HS1) Onsite/Home AED recalled

Philips Electronics North America is recalling Philips HeartStart (HS1) Onsite/Home AED, distributed nationwide in the US. The recall was initiated on 14 Mar 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesManufactured between September 2002 and February 2013. The year of manufacture can be identified by the 2nd and 3rd characters in the serial number on the back of the AED in the following ranges: Home/Onsite: A02x-xxxxx through A13B-xxxxx; FRx: B04x-xxxxx through B13B-xxxxx NOTE: If the device was manufactured in 2013 and the 4th digit is the letter "C" or later (D, E, F...), it is not covered by the recall (i.e. A13G-02375). In some cases, a device within the date range covered by the notification did not contain a resistor previously associated with a failure. In that case, a notification was not sent. Confirmation as to whether the device contains the resistor at issue can be done by contacting the firm.

Quantity recalledTotal for FRx and HS1 - 660,519 defibrillators

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1914-2018
FDA event ID: 79343
Recalling firm: Philips Electronics North America, Bothell, WA
Classification: Class II
Status: Terminated
Recall initiated: 14 Mar 2018
FDA classified: 23 May 2018
Reported: 30 May 2018
Type: FDA Mandated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

14 Mar 2018	Recall initiated by company
23 May 2018	Classified by FDA	+70 days
30 May 2018	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

An issue with one of the electric components (a resistor) could result in the device not delivering a shock when needed.

Product as listed by the FDA

Philips HeartStart (HS1) Onsite/Home AED

Where it was distributed

Distribution was nationwide and to Puerto Rico. There was also government/military distribution. Foreign distribution was made to the following countries: Canada, Afghanistan, Algeria, Argentina, Aruba, Australia, Austria, Bahrain, Bangladesh, Belgium, Bolivia, Botswana, Brazil, Brunei Darussalam, Cambodia, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Fiji, Finland, France, Georgia, Germany, Ghana, Greece, Guatemala, Hong Kong, Iceland, India, Indonesia, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Kenya, Republic of Korea, Kuwait, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Macao, Malaysia, Malta, Mauritius, Mexico, Morocco, Namibia, Netherlands, Netherlands Antilles, New Caledonia, New Zealand, Niger, Norway, Oman, State of Palestine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Sri Lanka, Suriname, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Thailand, Trinidad and Tobago, Tunisia, Turkey, Turkmenistan, Ukraine, United Arab Emirate, United Kingdom, Uzbekistan, Venezuela, Viet Nam, Yemen, Zambia, and Zimbabwe.

Nationwide Georgia Puerto Rico

Questions about this recall

Is Philips HeartStart (HS1) Onsite/Home AED recalled?

Yes. Philips Electronics North America recalled Philips HeartStart (HS1) Onsite/Home AED on 14 Mar 2018. The recall is Class II and its status is Terminated. Recall number Z-1914-2018.

Why was it recalled?

An issue with one of the electric components (a resistor) could result in the device not delivering a shock when needed.

Which lots are affected?

Manufactured between September 2002 and February 2013. The year of manufacture can be identified by the 2nd and 3rd characters in the serial number on the back of the AED in the following ranges: Home/Onsite: A02x-xxxxx through A13B-xxxxx; FRx: B04x-xxxxx through B13B-xxxxx NOTE: If the device was manufactured in 2013 and the 4th digit is the letter "C" or later (D, E, F...), it is not covered by the recall (i.e. A13G-02375). In some cases, a device within the date range covered by the notification did not contain a resistor previously associated with a failure. In that case, a notification was not sent. Confirmation as to whether the device contains the resistor at issue can be done by contacting the firm.

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Philips Electronics North America

All 160

Reported	Class	Recall	Company	Reason	Where
19 Dec 2018Device	CLASS II	IntelliVue MX40 Patient Monitor recalled by Philips Electronics North	Philips Electronics North America	Device Malfunction	Nationwide
24 Oct 2018Device	CLASS II	Philips HeartStart FR3 Defibrillator recalled	Philips Electronics North America	Sterility	Nationwide
3 Oct 2018Device	CLASS II	Allura Xper F010, System recalled by Philips Electronics North	Philips Electronics North America	Other	Nationwide
3 Oct 2018Device	CLASS II	Allura Xper FD2O Biplane, System recalled by Philips Electronics North	Philips Electronics North America	Other	Nationwide
3 Oct 2018Device	CLASS II	AIIuraXperFDlO, System recalled by Philips Electronics North	Philips Electronics North America	Other	Nationwide

Other Other Medical Devices recalls

All 13,778

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Device	CLASS II	Citric Complete Dry Citric Acid Concentrate recalled	Nipro Renal Soultions USA	Other	Nationwide
16 Sep 2026Device	CLASS I	Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	Halyard IV Start Kit Non-Sterile recalled by Avid Medical	Avid Medical	Sterility	Nationwide
16 Sep 2026Device	CLASS I	Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	AMS Convenience Kit: Dsaek Pack - RX recalled	Windstone Medical Packaging	Device Malfunction	Nationwide