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Terminated

3D TOP Ceiling Stand. X-Ray System model number 8773673

FDA Recall Z-0335-06 · Posted 2005-12-31

Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeIYB
Date Initiated2005-11-30
Date Terminated2006-07-19
Product Quantity460 units

Reason for Recall

screws on the rollers may become loose

Firm Action

The recalling firm has issued a field correction per Update Instructions AX004/06/S. This update instructs a Siemens Customer Service Engineer to visit affected consignees and checkthe screws on the rollers. It also provides roller bearing sleeves as a secondary safety mechanism to prevent the rollers from detaching.

Root Cause

Other

Distribution Pattern

The products were shipped to hospitals and medical facilities nationwide.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K802200VERTIX 3D-USiemens Corp. · 1980-10-23

Official Source

View FDA Recall →

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

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