Recall Z-0081-2022
Philips North America LLC · initiated February 9, 2021
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Philips, HeartStart HS1 OnSite Defibrillator, Model #'s: M5066A and M5067A
Codes / lots: 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.
Reason for recall
Customers were not notified of previous recalls associated with various defibrillator models.
FDA-determined cause: Process control
Action taken
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.
Details
- Recall number
- Z-0081-2022
- Initiated
- February 9, 2021
- Posted by FDA
- October 8, 2021
- Product code
- MKJ – Automated External Defibrillators (Non-Wearable)
- Quantity
- 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.
- Recalling firm
- Philips North America LLC, Bothell, WA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0078-2022 Class II | Philips, HeartStart FR2 + Defibrillator, Model # M3860A and M3861ACustomers were not notified of previous recalls associated with various defibrillator models. | 02/09/2021Open, Classified |
| Z-0079-2022 Class II | Philips, HeartStart FRx + Defibrillator, Model # Model #s: 861304Customers were not notified of previous recalls associated with various defibrillator models. | 02/09/2021Open, Classified |
| Z-0080-2022 Class II | Philips, HeartStart HS1 Home Defibrillator, Model # Model number: M5068ACustomers were not notified of previous recalls associated with various defibrillator models. | 02/09/2021Open, Classified |