Z-0926-2022 Class II Ongoing
FDA device recall Z-0926-2022 was initiated by Philips North America, LLC on Feb 7, 2022 and is designated Class II. Reason for recall: Update to instructions for use regarding the cleaning and disinfection process for the reusable probes. The recall status is ongoing. Affected quantity: 478,931 units.
Recall Details
- Product Type
- Devices
- Report Date
- Apr 20, 2022
- Initiation Date
- Feb 7, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 478,931 units
Product Description
Reason for Recall
Distribution Pattern
Worldwide distribution: US (nationwide) Including Puerto Rico and OUS (foreign) countries including: Afghanistan, Albania, Algeria, Angola, Argentina, Aruba, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Barbados, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Botswana, Brazil, Brunei Darussalam, Bulgaria, Burundi, Cambodia, Canada, Chile, China, Columbia, Congo (Democratic Republic of the), Costa Rica, Cote D'lvoire, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Ethiopia, Finland, France, French Guiana, French Polynesia, Gabon, Georgia, Germany, Ghana, Greece, Guadeloupe, Guatemala, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Ireland, Israel, Japan, Jordan, Kazakhstan, Korea Republic of, Kuwait, Lao People's Democratic Republic, Latvia, Lebanon, Liberia, Libya, Lithuania, Luxembourg, Macao, Macedonia, Malaysia, Maldives, Mali, Malta, Mauritius, Mayotte, Mexico, Moldova, Mongolia, Montenegro, Morocco, Mozambique, Myanmar, Namibia, Nepal, Netherlands, Netherlands Antilles, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, State of, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Qatar, Reunion, Romania, Russian Federation, Rwanda, Saint Lucia, Saint Pierre and Miquelon, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, South Africa, Spain, Sri Lanka, Suriname, Swaziland, Sweden, Switzerland, Syrian and Republic, Taiwan, Tajikistan, Tanzania, Thailand, Trinidad and Tobago, Tunisia, Turkey, Turkmenistan, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, Viet Nam, Yemen and Zambia.
Code Information
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0926-2022
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026