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Class 2 Device Recall Philips, HeartStart HS1 OnSite Defibrillator |
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| Date Initiated by Firm |
February 09, 2021 |
| Date Posted |
October 08, 2021 |
| Recall Status1 |
Open3, Classified |
| Recall Number |
Z-0081-2022 |
| Recall Event ID |
88637 |
| PMA Number |
P160029 |
| Product Classification |
Automated external defibrillators (non-wearable) - Product Code MKJ
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| Product |
Philips, HeartStart HS1 OnSite Defibrillator, Model #'s: M5066A and M5067A |
| Code Information |
Affected serial numbers for Model # M5066A:
A11K-03264,
A07A-01278,
B07F-01268,
A10G-05443,
A06E-00929,
A06L-01867,
A06L-01678,
A07J-05837,
A10C-03623,
M5066A-ABD,
A07K-02685,
A09H-03908,
0205142344,
Expansion - additional serial numbers for Model # M5066A:
A11K-08837,
Affected Serial numbers for Model # M5067A:
A06K-02421. |
Recalling Firm/
Manufacturer |
Philips North America LLC
22100 Bothell Everett Hwy
Bothell WA 98021-8431
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| For Additional Information Contact |
Customer Services
1800-722-9377
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Manufacturer Reason
for Recall |
Customers were not notified of previous recalls associated with various defibrillator models.
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FDA Determined
Cause 2 |
Process control |
| Action |
On February 11, 2021, Philips issued a "Urgent - Safety Notification" to affected consignees via certified Mail. In addition to notifying consignees that may have been omitted from notification of one or more recalls, Philips asked affected consignees to take
1. To acknowledge receipt of this notification, please complete and return the Customer Reply Form by email or by fax by February 15, 2021.
Email to: ECR.Recall.Response@Philips.com
Or, Fax: 1 (833) 371-1011
2. A Philips representative will reach out to you to help you identify any affected AED.
3. After it has been confirmed that you have an affected AED and a replacement Philips AED has been sent to you, please return the affected AED to Philips using the shipping label to be provided.
4. The affected AED may remain in service until you receive a replacement Philips AED.
5. Philips will exchange affected devices with a replacement Philips AED free of charge.
6. If you need any further information or support concerning this issue, please contact Philips at 1 (800) 263-3342.
7. Adverse reactions or quality problems experienced with the use of this product
may be reported to the FDA s Med Watch Adverse Event Reporting program
either online, by regular mail or by fax.
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| Quantity in Commerce |
15 units |
| Distribution |
U.S.: CA, CT, FL, GA, IN, MI, MO, NJ, NY, OH, TX, and WA.
International distribution in the countries of Australia, Canada, France, Germany, Japan, Norway, Switzerland. |
| Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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