Sedecal SP-HF 4.0 Portable X-Ray System; Manufactured by SEDECAL, C/Pelya 9 Pol. Ind. Rio De Janeiro, 28110 Algete (Madr
FDA device recall Z-0001-04 · posted 2003-10-29 · Terminated
Recall details
- Recalling firm
- Sedecal USA, Inc
- 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 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- IZL
- Quantity affected
- 1 unit
- Distribution
- Vermont
- Date initiated
- 2003-10-27
- Date posted
- 2003-10-29
- Date terminated
- 2004-03-24
- Location
- Arlington Heights, IL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PORTABLE X-RAY UNITS; MODELS SP-HF-2.8 & SP-HF-4.0 (K020436) | Sedecal., Sa. | 2002-02-22 |