CLASS II Device recall · Reported 16 Apr 2014 · FDA Enforcement Report
Philips HeartStart XL+ Defibrillator/Monitor recalled
Philips Medical Systems is recalling Philips HeartStart XL+ Defibrillator/Monitor, distributed in Washington. The recall was initiated on 31 Mar 2014 and the FDA has classified it as Class II.
Check your package
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-1439-2014
- FDA event ID
- 67857
- Recalling firm
- Philips Medical Systems, Andover, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 31 Mar 2014
- FDA classified
- 9 Apr 2014
- Reported
- 16 Apr 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Pacemakers & Defibrillators
Timeline
| 31 Mar 2014 | Recall initiated by company | |
| 9 Apr 2014 | Classified by FDA | +9 days |
| 16 Apr 2014 | 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
A component on the HeartStart XL+ Therapy Board could malfunction potentially affecting the ability to deliver therapy
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Philips HeartStart XL+ Defibrillator/Monitor Model number: 861290, automatic external defibrillator.
Where it was distributed
Worldwide Distribution - US Distribution including the states of IN and WA., and the countries of : CHINA FRANCE GERMANY ITALY MALAYSIA PANAMA SAUDI ARABIA TURKEY and UNITED KINGDOM.
Questions about this recall
Why was it recalled?
A component on the HeartStart XL+ Therapy Board could malfunction potentially affecting the ability to deliver therapy
Which lots are affected?
Serial Numbers: USN1307680 USD1309181 USD1308456 USD1309182 USD1309167 USD1309184 USD1309168 USD1309194 USD1309180 USD1309195 USD1309196 USD1309274 USD1309197 USD1309286 USD1309227 USD1309301 USD1309264 US11409686 USD1309269
Where was it sold?
Worldwide Distribution - US Distribution including the states of IN and WA., and the countries of : CHINA FRANCE GERMANY ITALY MALAYSIA PANAMA SAUDI ARABIA TURKEY and UNITED KINGDOM.
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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