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 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Sedecal SP-HF 4.0 Portable X-Ray System; Manufactured by SEDECAL, C/Pelya 9 Pol. Ind. Rio De Janeiro, 28110 Algete (Madrid) Spain
Brand
Sedecal USA, Inc
Lot Codes / Batch Numbers
serial #PK10058
Products Sold
serial #PK10058
Sedecal USA, Inc is recalling Sedecal SP-HF 4.0 Portable X-Ray System; Manufactured by SEDECAL, C/Pelya 9 Pol. Ind. Rio De Janeiro due to 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 Portab. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
VT
Page updated: Jan 10, 2026