Z-1092-2026 Class II Ongoing
FDA device recall Z-1092-2026 was initiated by C-RAD POSITIONING AB on October 9, 2025 and is designated Class II. Reason for recall: Due to issues with the system's stereotactic radiosurgery (SRS) treatment cannot be guaranteed for all couch angles and system setups. n certain cases, the system may indicate the patient as correctly… The recall status is ongoing. Affected quantity: 189.
Recall Details
- Product Type
- Devices
- Report Date
- January 21, 2026
- Initiation Date
- October 9, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 189
Product Description
Reason for Recall
Distribution Pattern
The software module cSRS has been installed in 37 countries Worldwide - U.S. Nationwide distribution in the states of AK, AL, AR, CA, CT, FL, MO, NC, NM, NY, OH, OK, OR, PA, TN, TX, VA, and WA. The countries of Argentina, Australia, Austria, Belarus, Belgium, Benin, Canada, China, Colombia, Egypt, El Salvador, Finland, France, Germany, Greece, Hungary, India, Italy, Japan, Jordan, Mexico, Morocco, Netherlands, New Zealand, Norway, Portugal, Romania, Russia, Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, Ukraine, and Vietnam.