FDA Recall Terminated

MobileDiagnost wDR motorized portable diagnostic X-ray systems.

Recall: Z-1040-2015 · Initiated August 6, 2014

Recall

Recall Number
Z-1040-2015
Event Number
70237
Firm
Sedecal S.A. C/Pelaya, 9-13 Pol. Industrial Rio De Janiero Algete Spain
FEI Number
3002495042
Product Code
IZL
Status
Terminated
Root Cause
Other
Initiated
August 6, 2014
Posted
February 2, 2015
Terminated
June 22, 2016

Description

MobileDiagnost wDR motorized portable diagnostic X-ray systems.

Reason

Reports of unexpected movement.

Action

URGENT - Field Safety Notice letters dated August 6, 2014 were sent to all consignees of record. The letters instructed consignees: 1) The unit is equipped with a safety switch in the drive handle. If the drive handle is released the unit will stop; 2) Do not try to correct unintended movement using the controls on the drive handle; 3) Instead, stop the system immediately by releasing the drive handle entirely; 4) Alternatively, the emergency button can be pressed; 5) Take special care when the system crosses metal strips or plates on the floor or enters an elevator, as these are situations where electrostatic discharge is likely to occur; and, 6) Should the customer feel uncertain regarding this action, he/she can contact Philips Healthcare.

Distribution

US: Nationwide (AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NM, NY, OH, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI)

Quantity

283 systems