September 25, 2026

Sep

FDA Recall: Software Problem when in Split or Local Function

September 25, 2026Allison PateNews

Company: Shanghai United Imaging Healthcare Co., Ltd. Date of Enforcement Report: 9/25/2026 Class: II PRODUCT Computed Tomography X-ray System, Model: uCT 550 with software Recall Number: Z-3278-2026 REASON: 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...

Sep

FDA Recall: Software Error Resulting in Need for Rescans

September 25, 2026Allison PateNews

Company: Shanghai United Imaging Healthcare Co., Ltd. Date of Enforcement Report: 9/25/2026 Class: II PRODUCT Computed Tomography X-ray System, Model: uCT 530 with software Recall Number: Z-3277-2026 REASON: 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...

Sep

FDA Recall: Software system mixing patient records

September 25, 2026Allison PateNews

Company: Volcano Corp Date of Enforcement Report: 9/25/2026 Class: II PRODUCT Philips IntraSight Plus REF: 797423 and 797417 100-120v-220-240v,50/60hZ, 1000 VA Recall Number: Z-3276-2026 REASON: Software system may associate image data from one patient with another patient’s record, potentially resulting in incorrect diagnosis or treatment. RECALLING FIRM/MANUFACTURER: Volcano Corp VOLUME: 19 systems DISTRIBUTION: Worldwide –...

FDA Recall: Software Problem when in Split or Local Function

FDA Recall: Software Error Resulting in Need for Rescans

FDA Recall: Software system mixing patient records

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FDA Recall: Software Problem when in Split or Local Function

FDA Recall: Software Error Resulting in Need for Rescans

FDA Recall: Software system mixing patient records

Upcoming Public Courses

Corporate Office