ModerateClass IITerminated

FDA Devices recall · Reported April 22, 2020

Positron Emission Tomograpy and Computed Tomography System, Model: uMI 550, with software version R001.3.0.0.750505, Rx Only, CE 0197, UDI: (01)06971576832026 - Product Usage: This system is 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.

Q: Which agency issued this recall?

This recall was issued by the FDA Devices on April 22, 2020. Severity: Moderate. Recall number: Z-1708-2020.

Q: Where was the recalled product distributed?

Distribution: US Nationwide distribution in the state TX..

Q: How do I check if my product is affected by a recall?

Check the product description and recall number (Z-1708-2020) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.

Q: Should I stop using a recalled medication or medical device?

Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

Potential sporadic software bugs in R001.3.0.0.750505 software version may cause an issue with the PET acquisition raw data causing reconstruction problems during PET/CT scanning …

Recall #: Z-1708-2020
Affected scope: 2 units
Initiated: August 26, 2019

Compiled from official public sources by the editorial team. · Updated August 2026

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Shanghai United Imaging Healthcare Co., Ltd. recalled Positron Emission Tomograpy and Computed Tomography System, Model: uMI 550, with software… - a moderate-severity action.

Positron Emission Tomograpy and Computed Tomography System, Model: uMI 550, with software… was recalled by Shanghai United Imaging Healthcare Co., Ltd. in April 22, 2020. Reason: Potential sporadic software bugs in R001.3.0.0.750505 software version may cause an issue with the PET acquis…. Check the official notice for the remedy. Verify recall #Z-1708-2020 with the FDA Devices before acting.

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The recall

Shanghai United Imaging Healthcare Co., Ltd. issued this moderate-severity FDA Devices recall-Potential sporadic software bugs in R001.3.0.0.750505 software version may cause an issue with the PET acquis….

Moderate
severity level: 2 units
affected scope: Class II
classification: April 22, 2020
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-1708-2020 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This FDA Devices action (record #Z-1708-2020) was formally reported on April 22, 2020, with the manufacturer initiating the action on August 26, 2019. It is classified under Moderate severity (Class II), with a current status of Terminated. Shanghai United Imaging Healthcare Co., Ltd. is listed as the recalling firm, operating out of Shanghai. Federal records list the affected scope as 2 units.

The documented reason for this recall is: Potential sporadic software bugs in R001.3.0.0.750505 software version may cause an issue with the PET acquisition raw data causing reconstruction problems during PET/CT scanning and could possibly cause rescans of pati… Distribution data in the federal record shows the product reached: US Nationwide distribution in the state TX.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.

Where this recall sits in the database

Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.

Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.

Severity

Moderate

Affected scope

2 units

Related Recalls

3 from same agency

Product description

Positron Emission Tomograpy and Computed Tomography System, Model: uMI 550, with software version R001.3.0.0.750505, Rx Only, CE 0197, UDI: (01)06971576832026 - Product Usage: This system is 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.

Reason for recall

Potential sporadic software bugs in R001.3.0.0.750505 software version may cause an issue with the PET acquisition raw data causing reconstruction problems during PET/CT scanning and could possibly cause rescans of patients with additional dose.

Recall Profile

Structured summary of the FDA Devices recall record
Attribute	Value
Agency	U.S. Food and Drug Administration
Severity class	Moderate (Class II)
Status	Terminated
Recall number	Z-1708-2020
Date reported	April 22, 2020
Date initiated	August 26, 2019
Recalling firm	Shanghai United Imaging Healthcare Co., Ltd.
Firm location	Shanghai
Affected scope	2 units
Distribution	US Nationwide distribution in the state TX.

Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.

Scale of Impact

2 units units affected - limited or regional distribution scale.

Regional (<10K units) ✓ This recall

Multi-state (10K – 100K units) -

Large-scale (100K – 1M units) -

Massive (≥1M units) -

Bracket cutoffs follow federal recall-disclosure conventions; bar widths scale linearly within each bracket. Source: PlainRecalls analysis of U.S. Food and Drug Administration filings.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

Check the recall number (Z-1708-2020) and product description against the item you own. Search the archive
Confirm the current status with FDA Devices before acting, recall details can be updated.
Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next

This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.

Frequently Asked Questions

What product was recalled? ▼

Why was this product recalled? ▼

Which agency issued this recall? ▼

This recall was issued by the FDA Devices on April 22, 2020. Severity: Moderate. Recall number: Z-1708-2020.

Where was the recalled product distributed? ▼

Distribution: US Nationwide distribution in the state TX..

How do I check if my product is affected by a recall? ▼

Check the product description and recall number (Z-1708-2020) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.

Should I stop using a recalled medication or medical device? ▼

Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported April 22, 2020. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.