Is Biograph mCT S(40)-4R, Model Number 10248671 recalled?

Emission computed tomography systems and computed tomography xray systems with optional ceiling mounts may be missing a locking ring. Status: Voluntary: Firm initiated Initial Firm Notification: Telephone Distribution: Distributed in the state of Texas and the countries of Germany, France, Russia, Denmark, and Switzerland.

Medium RiskFDA Device

Siemens Medical Solutions USA Inc.: Emission computed tomography systems and computed tomography xray systems with optional ceiling mounts may be missing a locking ring.

Agency Publication Date: August 5, 2015

Affected Products

Product: Biograph mCT S(40)-4R, Model Number 10248671

SERIAL NUMBER 11073

Product: Biograph mCT S(64)-4R, Model Number 10248672

SERIAL NUMBER 11026

Product: Biograph mCT X-4R, Model Number 10248670

SERIAL NUMBERS: 1009, 11061

Product: SYS IVK, Bio mCT-S(40) 3R->4R, Model Number 10250743

SERIAL NUMBER 11004

Product: Biograph mCT Flow Edge-4R, Model Number 10528955

SERIAL NUMBERS: 11002, 11005, 1008

Product: Biograph 6-4R TruePoint w/ TrueV, Model Number 10097290

SERIAL NUMBER 45590

Product: Biograph 64-4R TruePoint w/ TrueV, Model Number 10097302

SERIAL NUMBERS: 1041, 1042

Product: Biograph 64-3R TruePoint w/ TrueV, Model Number 10097301

SERIAL NUMBER 1020

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 71712

Status: Resolved

Manufacturer: Siemens Medical Solutions USA Inc.

Manufactured In: United States

Units Affected: 8 products (1 unit; 1 unit; 2 units; 1 unit; 3 units; 1 unit; 2 units; 1 unit)

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

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