Sedecal SP-HF 4.0 Portable X-Ray System; Manufactured by SEDECAL, C/Pelya 9 Pol. Ind. Rio De Janeiro, 28110 Algete (Madrid) Spain
This recall has been terminated (originally issued October 29, 2003).
- Company
- Sedecal Usa, Inc.
- Recall Initiated
- October 27, 2003
- Posted
- October 29, 2003
- Terminated
- March 24, 2004
- Recall Number
- Z-0001-04
- Quantity
- 1 unit
- Firm Location
- Arlington Heights, IL
- Official Source
- View on FDA website ↗
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.
Distribution
Vermont
Lot / Code Info
serial #PK10058
Root Cause
Other
Action Taken
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.
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Sedecal X-Ray High Voltage Generators and Controls; Manufactured by SEDECAL, C/Pelya 9 Pol. Ind. Rio...
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