Medical Device Recall: Z-0001-04

FDA Recalls dataset · Firm: Sedecal USA, Inc · Status: Terminated

Recall Action Class: N/A Date Initiated: 2003-10-27 Recall record compiled from public FDA source records.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0001-04.

Recall Res Number
Z-0001-04
Recalling Firm / Manufacturer
Sedecal USA, Inc
FEI Number
1000139935
Recall Status
Terminated
Recall Classification
N/A
Date Initiated
2003-10-27
Date Posted
2003-10-29
Date Terminated
2004-03-24
Product Code
IZL--
Event Number
27549
Product Quantity
1 unit
Product Description Sedecal SP-HF 4.0 Portable X-Ray System; Manufactured by SEDECAL, C/Pelya 9 Pol. Ind. Rio De Janeiro, 28110 Algete (Madrid) Spain
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.
Action Details 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.
Distribution Pattern Vermont
Code Information / Serial Numbers serial #PK10058

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