Recall Z-0001-04 ยท IZL System, X-Ray, Mobile
Sedecal USA, Inc
Sedecal SP-HF 4.0 Portable X-Ray System; Manufactured by SEDECAL, C/Pelya 9 Pol. Ind. Rio De Janeiro, 28110 Algete (Madrid) Spain
| Date | Oct 29, 2003 (initiated Oct 27, 2003) |
| Status | Terminated |
| 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. |
| Root cause | Other |
| 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. |
| Quantity | 1 unit |
| Distribution | Vermont |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K020436 | PORTABLE X-RAY UNITS; MODELS SP-HF-2.8 & SP-HF-4.0 Sedecal., Sa., Feb 22, 2002 |