Z-1007-2026 Class II
FDA device recall Z-1007-2026 was initiated by Philips Ultrasound, LLC on Jul 14, 2022 and is designated Class II. Reason for recall: Retroactive: Ultrasound may experience an unexpected automatic reboot, resulting in damage to transducer. Affected quantity: 1,721 systems.
Recall Details
- Product Type
- Devices
- Report Date
- Jan 7, 2026
- Initiation Date
- Jul 14, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,721 systems
Product Description
Reason for Recall
Distribution Pattern
Worldwide - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and the countries of Argentina, Australia, Belgium, Canada, Chile, Colombia, Czech Republic, Denmark, Ecuador, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Iran, Iraq, Ireland, Israel, Italy, Japan, Korea, Republic of Latvia, Lithuania, Morocco, Netherlands , New Zealand, Oman, Panama, Philippines, Poland, Romania, Russian Federation, Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Thailand, Turkey, United Arab Emirates, United Kingdom.
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-1007-2026
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026