← Search recalls
FDA (Device enforcement)Recalled 2019-06-12class ii

ZOLL Medical Corporation: ZOLL AED PRO Automated External Defibrillator Product Usage: The AED PRO unit is intended to defibrillate victims of ventricular fibrillation or pulseless ventricular tachyca

Is my product affected?

ZOLL AED PRO Automated External Defibrillator Product Usage: The AED PRO unit is intended to defibrillate victims of ventricular fibrillation or pulseless ventricular tachycardia, for ECG monitoring, and for CPR monitoring of patients. The CPR monitoring function provides a metronome designed to enc

  • UPC 00847946016128
  • UPC 00847946016142
  • UPC 00847946015138
  • UPC 00847946016135
  • UPC 00847946016166

Check against the official notice below — it lists the full affected range.

What happened

ZOLL Medical Corporation has recalled 1,969 AED PRO Automated External Defibrillators distributed worldwide, including throughout the United States and 21 other countries. The devices have a potential defect that could cause them to fail to deliver energy to a patient during use. The affected units can be identified by specific part numbers, GTINs, and serial numbers beginning with AA17 or AA18.

The recall record does not specify what actions affected consumers should take in response to this recall.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

There is a potential for the device to fail to deliver energy to the patient.

Details from the source

Reason for recall: There is a potential for the device to fail to deliver energy to the patient. Distribution: Worldwide Distribution - US nationwide. The products were distributed to the following foreign countries: Austria, Australia, Bangladesh, Brazil, Canada, China, Denmark, France, Germany, Great Britain, Indonesia, Italy, Japan, Luxemburg, New Zealand, Panama, Russia, Saudi Arabia, Singapore, Spain, Thailand, Taiwan. Quantity: 1,969 Lot/code info: Part Numbers: 90010200499991010, 90010400499991010, 70010400499991010, 90010202499991010, 90010600499991010; GTIN: 00847946016128, 00847946016142, 00847946015138, 00847946016135, 00847946016166 Serial Numbers: AA17C041915 AA17C041916 AA17J043664 AA17J043666 AA17J043670 AA17J043671 AA17J043672 AA17J043673 AA17J043674 AA17J043675 AA17J043682 AA17J043683 AA17J043725 AA17J043813 AA17J043814 AA17J043817 AA17J043820 AA17J043825 AA17L044265 AA18B044867 AA18B044868 AA18B044869 AA18B044870 AA18B044871 AA18B044872 AA18B044873 AA18B044874 AA18B044875 AA18B044877 AA18B044878 AA18B044879 AA18B044880 AA18B044881 AA18B044882 AA18B044883 AA18B044884 AA18B044885 AA18B044886 AA18C044887 AA18C044888 AA18C044889 AA18C044890 AA18C044891 AA18C044892 AA18C044893 AA18C044894 AA18C044895 AA18C044896 AA18C044897 AA18C044898 AA18C044899 AA18C044900 AA18C044901 AA18C044902 AA18C044903 AA18C044904 AA18C044905 AA18C044906 AA18C044907 AA18C044908 AA18C044909 AA18C044910 AA18C044911 AA18C045011 AA18C045012 AA18C045013 AA18C045014 AA18C045015 AA18C045016 AA18C045017 AA18C045018 AA18C045019 AA18C045020 AA18C045021 AA18C045022 AA18C045023 AA18C045024 AA18C045025 AA18C045026 AA18C045027 AA18C045028 AA18C045029 AA18C045030 AA18C045031 AA18C045032 AA18C045033 AA18C045034 AA18C045035 AA18C045036 AA18C045037 AA18C045038 AA18C045039 AA18C045040 AA18C045041 AA18C045042 AA18C045043 AA18C045044 AA18C045045 AA18C045046 AA18C045047 AA18C045048 AA18C045049 AA18C045050 AA18C045051 AA18C045052 AA18C045053 AA18C045054 AA18C0

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

Related recalls

All FDA (Device enforcement) recalls

Hurt by this product? Start a free Case Check

ProductRisk is not a law firm and does not provide legal services or legal advice. ProductRisk is a free consumer product-safety information service operated by Plaintify, Inc., a technology company. If you ask to be connected with a law firm, any legal services are provided by that firm — not by ProductRisk or Plaintify.

Privacy · Plaintify