Recalls / —

—#192435

Product

Symbia Intevo Bold and Symbia Intevo 6 SPECT/CT Systems

FDA product code

KPS — System, Tomography, Computed, Emission

Device class

Class 2

Medical specialty

Radiology

510(k) numbers

K200474

Affected lot / code info

A) Symbia Intevo Bold system; Model Number 11007962; Serial Numbers: 1) 1499 (UDI:40568690011591499) 2) 1501(UDI: 40568690011591501) 3) 1505 (UDI: 40568690011591505) 4) 1510 (UDI: 40568690011591510)  B) Symbia Intevo 6 system; Model Number 10764803; Serial Numbers: 1) 2352 (UDI: 40568690012342352) 2) 2353 (UDI: 40568690012342353) 3) 2354 (UDI: 40568690012342354)

Why it was recalled

There is a quality issue with the three bolts that hold the CT balancing weights, which could create a safety issue.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

Customer Advisory Notice Letter will be provided to each impacted consignee. Depending on the customer s capabilities, Siemens provides the letters via mail, e-mail, or hand delivery by a service engineer. The receipt of the letter will be documented, and additional attempts will be made until such receipt is acknowledged. The safety advisory letter informs customers: You may continue to use your system ensuring to follow all instructions in the Operator Manual. If any changes in system vibrations or noises are detected, then activate the Emergency Stop (E-Stop), discontinue use of the system immediately and contact your service engineer.

Recalling firm

Firm

Siemens Medical Solutions USA, Inc.

Address

2501 Barrington Rd, Hoffman Estates, Illinois 60192-2061

Distribution

Distribution pattern

Distribution OUS only to El Salvador, France, Germany, Japan, Taiwan, and UK.

Timeline

Recall initiated

2022-03-11

Terminated

2023-04-14

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #192435. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.