RadPro 40kW Digital X-Ray Panel and Mobile/Portable Diagnostic X-Ray. Intended for use by a qualified/trained doctor or
FDA device recall Z-2390-2015 · posted 2015-08-14 · Terminated
Recall details
- Recalling firm
- Sedecal S.A.
- Reason for recall
- Electrostatic energy may be stored in Systems that can cause a short-cicuit which, in turn, can generate an Electomagnetic Pulse which might disturb the electronics of the Digital Motion Control Board producing uncontrolled movements and such uncontrolled movements could cause the system to bump into the user or ppatient.
- Action taken
- FIELD CORRECTION NOTIFICATION letters dated July 13, 2015 were sent to all dealers. The letters instructed the dealers: to schedule the replacement of the current arrestor by a new design of resistive arrestor with a resistance of 1 M ohm between frame and floor (ground). Although the metallic arrestor is only implemented in the equipments manufactured from April 2013 till March 2015, the upgrade kit has to be implemented in all the installed base of Mobiles with the same configuration in order to ensure that even the arrestors installed as spare part are replaced. Sedecal will provide the necessary upgrade kits to all the customers or distributors. *** U.S. Distributor, Virtual Imaging (a Canon U.S.A. Company) will use letter entitled, FIELD CORRECTION NOTIFICATION, RADPRO 40kW - -DIGITAL MOBILE X-RAY SYSTEM and dated 7/13/2015 to communicate to end users. The letter states "Once Virtual Imaging receives the resistive arrestor, we will contact you to schedule the replacement on the Affected System that you service." Please contact Virtual Imaging, Inc.'s Technical Support for any questions at 561.893.8500 or technicalsupport@vifla.com. ****
- Root cause
- Device Design
- Status
- Terminated
- Product code
- IZL
- Quantity affected
- 361 systems (U.S.); 5 systems (Foreign)
- Distribution
- Distributed US (nationwide) and in Canada.
- Date initiated
- 2015-07-13
- Date posted
- 2015-08-14
- Date terminated
- 2018-02-20
- Location
- Algete, Spain
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SEDECAL MOBILE DIGITAL DIAGNOSTIC X-RAY (K101517) | Sedecal., Sa. | 2011-08-05 |