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Terminated

Sedecal SP-HF 4.0 Portable X-Ray System; Manufactured by SEDECAL, C/Pelya 9 Pol. Ind. Rio De Janeiro, 28110 Algete (Madrid) Spain

FDA Recall Z-0001-04 · Posted 2003-10-29

Recalling FirmSedecal USA, Inc
Recall StatusTerminated
Product CodeIZL
Date Initiated2003-10-27
Date Terminated2004-03-24
Product Quantity1 unit

Reason for Recall

A minimum source-skin-distance of less than 30 cm and not identifying the tube manufacturer on the tube housing label resulted in the SP-HF-4.0 Portable Systems not complying with the U.S. Federal performance standard.

Firm Action

An 'Important Safety Notice' dated 10/27/03 was sent to the one direct account on the same date, informing them of the non-compliances with the performance standard and requesting them to call Sedecal at 800-920-9525 to arrange for the modification of the x-ray unit at no cost to the user.

Root Cause

Other

Distribution Pattern

Vermont

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K020436PORTABLE X-RAY UNITS; MODELS SP-HF-2.8 & SP-HF-4.0Sedecal., Sa. · 2002-02-22

Official Source

View FDA Recall →

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

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