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Terminated

Siregraph CF X-Ray System. Fluoroscopic image intensified. Model number 4466041

FDA Recall Z-1476-04 · Posted 2004-09-18

Recall StatusTerminated
Product CodeJAA
Date Initiated2004-06-07
Date Terminated2005-08-18
Product Quantity1 unit

Reason for Recall

X-ray tube movement when table is tilted more than 90 degrees

Firm Action

The recalling firm issued a Customer DAfety Advisory letter dated 6/7/04 to the hospitals. The letter informs them of the potential problem and provides preventative measures to avoid its occurance.

Root Cause

Other

Distribution Pattern

The products were shipped to medical facilities in FL, IL, MI, NH, NJ, PA, and TX.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

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

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