ModerateClass IITerminated

FDA Devices recall · Reported June 27, 2018

Biograph mCT Systems: (a) Biograph mCT S(64)-3R, Material Number 10248669 Product Usage: The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information. The CT component produces cross-sectional images of the body by computer reconstruction of X-Ray transmission data from either the same axial plane taken at differen

Q: Which agency issued this recall?

This recall was issued by the FDA Devices on June 27, 2018. Severity: Moderate. Recall number: Z-2248-2018.

Q: Where was the recalled product distributed?

Distribution: Worldwide Distribution.

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

Check the product description and recall number (Z-2248-2018) 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.

Siemens Medical Solutions USA, Inc., Molecular Imaging business line became aware, through our supplier that some laser cover windows may fall off a limited population of the Biog…

Recall #: Z-2248-2018
Affected scope: 405 units
Initiated: May 29, 2018

Reviewed by PlainRecalls Editorial, Product Recalls Editorial Team

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Siemens Medical Solutions USA, Inc. recalled Biograph mCT Systems: (a) Biograph mCT S(64)-3R, Material Number 10248669 Product Usa… — a moderate-severity action.

Biograph mCT Systems: (a) Biograph mCT S(64)-3R, Material Number 10248669 Product Usa… was recalled by Siemens Medical Solutions USA, Inc. in June 27, 2018. Reason: Siemens Medical Solutions USA, Inc., Molecular Imaging business line became aware, through our supplier that …. Check the official notice for the remedy. Verify recall #Z-2248-2018 with the FDA Devices before acting.

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The recall

Siemens Medical Solutions USA, Inc. issued this moderate-severity FDA Devices recall — Siemens Medical Solutions USA, Inc., Molecular Imaging business line became aware, through our supplier that ….

Moderate
severity level: 405 units
affected scope: Class II
classification: June 27, 2018
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-2248-2018 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This FDA Devices action (record #Z-2248-2018) was formally reported on June 27, 2018, with the manufacturer initiating the action on May 29, 2018. It is classified under Moderate severity (Class II), with a current status of Terminated. Siemens Medical Solutions USA, Inc. is listed as the recalling firm, operating out of Hoffman Estates, IL. Federal records list the affected scope as 405 units.

The documented reason for this recall is: Siemens Medical Solutions USA, Inc., Molecular Imaging business line became aware, through our supplier that some laser cover windows may fall off a limited population of the Biograph mCT and Biograph mCT Flow systems. Distribution data in the federal record shows the product reached: Worldwide Distribution. 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, 6 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 100,165 recalls in the database, 23,668 are high severity, 72,097 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

405 units

Related Recalls

6 from same agency

Product description

Biograph mCT Systems: (a) Biograph mCT S(64)-3R, Material Number 10248669 Product Usage: The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information. The CT component produces cross-sectional images of the body by computer reconstruction of X-Ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles. The PET subsystem images and measures the distribution of PET radiopharmaceuticals in humans for the purpose of determining various metabolic (molecular) and physiologic functions within the human body and utilizes the CT for fast attenuation correction maps for PET studies and precise anatomical reference for the fused PET and CT images. The system maintains independent functionality of the CT and PET devices, allowing for single modality CT and / or PET diagnostic imaging. These systems are intended to be utilized by appropriately trained health care professionals to aid in detecting, localizing, diagnosing, staging and restaging of lesions, tumors, disease and organ function for the evaluation of diseases and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The images produced by the system can also be used by the physician to aid in radiotherapy treatment planning and interventional radiology procedures. (b) Biograph mCT S(40)-4R, Material Number 10248671 (c) Biograph mCT S(64)-4R, Material Number 10248672 (d) Biograph mCT X-4R, Material Number 10248670 (e) Biograph mCT X-3R, Material Number 10248673 (f) BIOGRAPH mCT 20 Excel, Material Number 10507786 (g) Biograph mCT Flow Edge-4R, Material Number 10528955 (h) Biograph mCT S(40)-3R, Material Number 10248668 (i) Bio mCT-S(40) 3R->4R Upgrade, Material Number 10250743 (j) Biograph mCT Flow 40-4R, Material Number 10529159 (k) Biograph mCT-X w/TrueV Upgrade, Material Number 10250745

Reason for recall

Siemens Medical Solutions USA, Inc., Molecular Imaging business line became aware, through our supplier that some laser cover windows may fall off a limited population of the Biograph mCT and Biograph mCT Flow systems.

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-2248-2018
Date reported	June 27, 2018
Date initiated	May 29, 2018
Recalling firm	Siemens Medical Solutions USA, Inc.
Firm location	Hoffman Estates, IL
Affected scope	405 units
Distribution	Worldwide Distribution

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

Scale of Impact

405 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-2248-2018) 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 June 27, 2018. Severity: Moderate. Recall number: Z-2248-2018.

Where was the recalled product distributed? ▼

Distribution: Worldwide Distribution.

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

Check the product description and recall number (Z-2248-2018) 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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What to do next

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Data Sources

Source: FDA, CPSC, and NHTSA federal recall databases. This recall: FDA Devices, reported June 27, 2018.

Source: FDA — Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
Source: CPSC — Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
Source: NHTSA — National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)

Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.

Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records — no number is typed in by an editor. 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 June 2026.