FDAClass II · Medical device · Recall Z-3282-2026 · Recalled October 7, 2026
Computed Tomography X-ray System recall — Shanghai United Imaging Healthcare Co., Ltd.
Agency report date: October 7, 2026.
1. Compare your item
This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.
US Nationwide distribution in the states of CA, PR, UT, WV, ND, NE, NC, TX, ID, LA, MT, FL, CO, IN, KY, AL, OH, MI, IA, MO, NY, NV, TN, WV, SC, WI, IL, MS, MA, NJ.
Agency product description and boundaries
Computed Tomography X-ray System, Model: uCT ATLAS Astound with software
Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.
If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.
2. Agency hazard and consumer action
FDA reports: Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are merged into a single study, that prevents patient images from being visible on the Patient Administration interface, which may result in the need for rescans.
No consumer remedy instructions are supplied in this record. Check the official notice and listed company contact for the agency’s current instructions.
Class II: may cause temporary or medically reversible health consequences.
US Nationwide distribution in the states of CA, PR, UT, WV, ND, NE, NC, TX, ID, LA, MT, FL, CO, IN, KY, AL, OH, MI, IA, MO, NY, NV, TN, WV, SC, WI, IL, MS, MA, NJ.
FDA event ID
99731
Recall initiated
August 11, 2026
FDA classified
September 25, 2026
FDA report date
October 7, 2026
Related recalls
Other medical device recalls from around the same time
Source: U.S. Food & Drug Administration. Agency excerpts come from the public data feed and may omit tables or later changes;
the linked government source is authoritative. Source last checked October 22, 2026 at 12:00 PM UTC. Record retrieved October 22, 2026 at 12:00 PM UTC.