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Terminated

Symbia Intevo Bold and Symbia Intevo 6 SPECT/CT Systems

FDA Recall Z-0893-2022 · Posted None

Recalling FirmSiemens Medical Solutions USA, Inc.
Recall StatusTerminated
Product CodeKPS
Date Initiated2022-03-11
Date Terminated2023-04-14
Product Quantity7 devices

Reason for Recall

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

Firm Action

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.

Root Cause

Nonconforming Material/Component

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K200474Symbia 6.7Siemens Medical Solutions USA, Inc. · 2020-03-20

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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