Z-0448-2021Class II

Positron Emission Tomography and Computed Tomography System, Model uMI 550, Rx, CE, GTIN: 06971576832026 -

Name: Z-0448-2021 Positron Emission Tomography and Computed Tomography System, Model uMI 550, Rx, CE, GTIN: 06971576832026 -
Creator: Shanghai United Imaging Healthcare Co., Ltd.
Published: 2020-08-05
License: https://open.fda.gov/license/

Shanghai United Imaging Healthcare Co., Ltd. / initiated 2020-08-05 / Open, Classified / root cause: software

FDA source

Shanghai United Imaging Healthcare Co., Ltd. began a recall of Positron Emission Tomography and Computed Tomography System, Model uMI 550, Rx, CE, GTIN: 06971576832026 - Product Usage: intended to be operated by qualified... on 2020-08-05. FDA classified it as Class II and gives the reason as "A potential issue of an incorrect CT scan delay timer to be displayed on the gantry Digital Display Panel (DDP) during multi-phase contrast scanning. This could lead the operator to receive unnecessary exposure to...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-0448-2021
Classification: Class II
Status: Open, Classified
Initiated: 2020-08-05
Posted: 2020-11-12
Recalling firm: Shanghai United Imaging Healthcare Co., Ltd.
Product: Positron Emission Tomography and Computed Tomography System, Model uMI 550, Rx, CE, GTIN: 06971576832026 - Product Usage: intended to be operated by qualified healthcare professionals to assist in the detection, localization, diagnosis, staging, restaging, treatment planning and treatment response evaluation for diseases and disorders in, but not limit to, oncology, cardiology and neurology.
Product code: KPS System, Tomography, Computed, Emission
Reason for recall: A potential issue of an incorrect CT scan delay timer to be displayed on the gantry Digital Display Panel (DDP) during multi-phase contrast scanning. This could lead the operator to receive unnecessary exposure to radiation.
Root cause tag: software
FDA root cause: Software design
Action: The firm sent notification letters via email to distributorsThe firm's consignee hand delivered a written Field Safety Notification to end-users on June 11, 2020 to inform them that the delay time displayed on the DDP can be incorrect for a timed scan such as a multi-phase contrast scan. The DDP is located on the gantry in the scan room. If the operator enters the scan room to perform any multi-phase contrast scan and refers to the incorrect delay time displayed on the DDP, he or she may not be able to leave the scan room before the scan starts, and as a result may receive unnecessary radiation dose. The letter states the following: The purpose of this letter is to advise you that United Imaging is voluntarily correcting some of the uCT 530, uCT 550, uCT 760 The uCT 530 and uMI 550 devices. Reason for the Voluntary Correction: We are aware of one complaint associated with the device. We have not received any report that have resulted in injury. Safety Issue: A potential issue of an incorrect CT scan delay timer to be displayed on the gantry Digital Display Panel (DDP) during multi-phase contrast scanning. Risk to Health of Safety Issue: The delay time displayed on the DDP can be incorrect for a timed scan such as a multi-phase contrast scan. The DDP is located on the gantry in the scan room. If the operator enters the scan room to perform any multi-phase contrast scan and refers to the incorrect delay time displayed on the DDP, he or she may not be able to leave the scan room before the scan starts, and as a result may receive unnecessary radiation dose. Actions to be taken by the Customer I User: 1. During a multi-phase contrast scan, do not perform any operations on the Preview image of any previous phases. 2. If possible, avoid entering the scan room when performing multi-phase contrast scans. 3. If it is necessary to enter the scan room when performing a multi-phase contrast scan, ignore the potentially incorrect delay time displayed on the
Quantity in commerce: 9
Distribution: US Nationwide distribution including in the state of TX.
Product codes and lots: Serial Numbers: 200017, 200023, 200024, 200036, 200045, 200047, 230002, 230003, 230004

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0448-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0445-2021	Class II	Ongoing	Voluntary: Firm initiated	2020-11-18	2020-11-12
Z-0446-2021	Class II	Ongoing	Voluntary: Firm initiated	2020-11-18	2020-11-12
Z-0447-2021	Class II	Ongoing	Voluntary: Firm initiated	2020-11-18	2020-11-12
Z-0448-2021	Class II	Ongoing	Voluntary: Firm initiated	2020-11-18	2020-11-12

Product code KPS

K182237Class IIuMI 550 PET/CT SystemShanghai United Imaging Healthcare Co., Ltd. / cleared 2018-10-12

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)