FDA Recall
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
Recall: Z-0001-04
·
Initiated October 27, 2003
Recall
- Recall Number
- Z-0001-04
- Event Number
- 27549
- Firm
- Sedecal USA, Inc
- FEI Number
- 1000139935
- Product Code
- IZL--
- Status
- Terminated
- Root Cause
- Other
- Initiated
- October 27, 2003
- Posted
- October 29, 2003
- Terminated
- March 24, 2004
- Address
- 2910 N Arlington Heights Rd, Arlington Heights, IL, 60004-1551
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
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
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
Vermont
Quantity
1 unit