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Terminated

Mobile wDR motorized portable diagnostic X-ray systems. Intended for use by a qualified/trained doctor or technologist on both adult and pediatric patients for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts on both adult and pediatric patients. Applications can be performed with patient sitting, standing or lying in the prone or supine positions. Not intended for mammography.

FDA Recall Z-1084-2016 · Posted None

Recalling FirmSedecal S.A.
Recall StatusTerminated
Product CodeIZL
Date Initiated2016-01-18
Date Terminated2018-02-07
Product Quantity349 systems

Reason for Recall

This is related to previous 806 Notifications about uncommanded movements of a motorized mobile x-ray system. Reason for Recall: Along with the previously noted encoder and gauges problems and corresponding fixes, we have observed that static electricity can also elicit the unwanted behavior.

Firm Action

Philips Medical Systems sent an URGENT - Field Safety Notice letter dated August 6, 2014 was sent to all consignees of record informing them of a potential safety issue on the SEDECAL mobile units manufactured from May 2013 on. The firm requests the direct acounts with affected units should take the following steps: 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. Philips is preparing a Field Action Kit to replace the existing arrestor strap by a new arrestor with higher resistivity. This will reduce the electromagnetic pulse to a level, which is safe to not disturb the electronics. A Philips Service Engineer will contact the direct accounts to distribute Field Action Kit. The firm states that should direct accounts need to communicate with Philips in regards to this recall that they reference FC0-71200138. If they need any further information or support concerning this issue, please contact their local Philips representative.

Root Cause

Device Design

Distribution Pattern

Nationwide Distribution including 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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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