Z-2134-2020 Class II Terminated
FDA device recall Z-2134-2020 was initiated by Philips North America, LLC on April 20, 2020 and is designated Class II. Reason for recall: Internal Paddles may wear over time and may not be safe or ready for use, unless the directions in the Instructions for Use (IFU) to perform routine operational checks are followed. The instructions f… The recall status is terminated (terminated April 2, 2021). Affected quantity: 21,683 Internal Paddle Sets..
Recall Details
- Product Type
- Devices
- Report Date
- June 3, 2020
- Initiation Date
- April 20, 2020
- Termination Date
- April 2, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 21,683 Internal Paddle Sets.
Product Description
Reason for Recall
Distribution Pattern
Worldwide distribution - US Nationwide distrubtion and the countries of Albania, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Bolivia, Botswana, Brazil, Bulgaria, Cambodia, Canada, Chile, China, Colombia, Congo (Democratic Republic of the), Costa Rica, C¿te D'Ivoire, Cyprus, Czech Republic, Dominican Republic, Ecuador, Egypt El Salvador, Estonia, Finland, France, Gabon, Georgia, Germany, Greece, Guatemala, Haiti, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of Lao People's , Democratic Republic Latvia, Lebanon, Libya, Macao, Macedonia, Malaysia, Maldives, Mauritius, Mexico, Montenegro, Morocco, Myanmar, Namibia, Nepal, Netherlands, New Zealand, Nicaragua, Norway, Oman Pakistan, Palestine, State of Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania Russian Federation, Saudi Arabia, Serbia, Singapore Slovakia, South Africa, Spain, Sri Lanka, Sweden, Switzerland Syrian Arab Republic, Taiwan, Thailand, Tunisia, Turkey Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Viet Nam.