Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported March 26, 2014
Philips HeartStart Home and OnSite (HS1) automated external defibrillators (AEDs). Product Usage: The models M5066A, M5067A, and M5068A are designed for use on a person in sudden cardiac arrest who is: -Unresponsive when shaken -Not breathing normally If in doubt, apply the pads. A training class in CPR/AED use is recommended for anyone who may use the HS1. If the person is an infant or child younger than eight years old or weighs less than 55 lbs (25 kg), use the special infant/child pads.
Philips is recalling HeartStart Home and OnSite (HS1) automated external defibrillators (AEDs) because one or both contact pins may be contaminated by residue from the soldering p…
Philips Medical Systems North America Inc. recalled Philips HeartStart Home and OnSite (HS1) automated external defibrillators (AEDs). Pr… - a moderate-severity action.
Philips HeartStart Home and OnSite (HS1) automated external defibrillators (AEDs). Pr… was recalled by Philips Medical Systems North America Inc. in March 26, 2014. Reason: Philips is recalling HeartStart Home and OnSite (HS1) automated external defibrillators (AEDs) because one or…. Check the official notice for the remedy. Verify recall #Z-1232-2014 with the FDA Devices before acting.
The recall
Philips Medical Systems North America Inc. issued this moderate-severity FDA Devices recall-Philips is recalling HeartStart Home and OnSite (HS1) automated external defibrillators (AEDs) because one or….
- Moderate
- severity level
- 5K units
- affected scope
- Class II
- classification
- March 26, 2014
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1232-2014 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1232-2014) was formally reported on March 26, 2014, with the manufacturer initiating the action on February 6, 2014. It is classified under Moderate severity (Class II), with a current status of Terminated. Philips Medical Systems North America Inc. is listed as the recalling firm, operating out of Bothell, WA. Federal records list the affected scope as 5075 units total (2724 units in the US and 2351 units outside the US).
The documented reason for this recall is: Philips is recalling HeartStart Home and OnSite (HS1) automated external defibrillators (AEDs) because one or both contact pins may be contaminated by residue from the soldering process. This contamination could prevent… Distribution data in the federal record shows the product reached: Worldwide Distribution - USA Nationwide. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
5075 units total (2724 units in the US and 2351 units outside the US)
Related Recalls
6
3 from same agency
Product description
Philips HeartStart Home and OnSite (HS1) automated external defibrillators (AEDs). Product Usage: The models M5066A, M5067A, and M5068A are designed for use on a person in sudden cardiac arrest who is: -Unresponsive when shaken -Not breathing normally If in doubt, apply the pads. A training class in CPR/AED use is recommended for anyone who may use the HS1. If the person is an infant or child younger than eight years old or weighs less than 55 lbs (25 kg), use the special infant/child pads. If the child appears older/larger, use the adult pads. Do not delay treatment to determine the child s exact age or weight. If in doubt, use the adult pads. Models M5066A (for HS1 Onsite), M5067A (OnSite) , and M5068A (for HS1 Home).
Reason for recall
Philips is recalling HeartStart Home and OnSite (HS1) automated external defibrillators (AEDs) because one or both contact pins may be contaminated by residue from the soldering process. This contamination could prevent an adequate connection between the pads cartridge and the AED. If poor contact between the pads cartridge and AED occurs, the device may be unable to deliver therapy in an emergency.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1232-2014 |
| Date reported | March 26, 2014 |
| Date initiated | February 6, 2014 |
| Recalling firm | Philips Medical Systems North America Inc. |
| Firm location | Bothell, WA |
| Affected scope | 5075 units total (2724 units in the US and 2351 units outside the US) |
| Distribution | Worldwide Distribution - USA Nationwide |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1232-2014) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
Philips HeartStart Home and OnSite (HS1) automated external defibrillators (AEDs). Product Usage: The models M5066A, M5067A, and M5068A are designed for use on a person in sudden cardiac arrest who is: -Unresponsive when shaken -Not breathing normally If in doubt, apply the pads. A training class in CPR/AED use is recommended for anyone who may use the HS1. If the person is an infant or child younger than eight years old or weighs less than 55 lbs (25 kg), use the special infant/child pads. If the child appears older/larger, use the adult pads. Do not delay treatment to determine the child s exact age or weight. If in doubt, use the adult pads. Models M5066A (for HS1 Onsite), M5067A (OnSite) , and M5068A (for HS1 Home).. Recalled by Philips Medical Systems North America Inc.. Units affected: 5075 units total (2724 units in the US and 2351 units outside the US).
Why was this product recalled? ▼
Philips is recalling HeartStart Home and OnSite (HS1) automated external defibrillators (AEDs) because one or both contact pins may be contaminated by residue from the soldering process. This contamination could prevent an adequate connection between the pads cartridge and the AED. If poor contact between the pads cartridge and AED occurs, the device may be unable to deliver therapy in an emergency.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 26, 2014. Severity: Moderate. Recall number: Z-1232-2014.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - USA Nationwide.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1232-2014) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported March 26, 2014. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.