Sedecal S.A.: 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.

Recall number

Z-1084-2016

Recalling firm

Sedecal S.A.

Product

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.

Status

Terminated

Initiated

2016-01-18

Posted

not on file

Terminated

2018-02-07

Reason

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.

Root cause

Device Design

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.

Quantity

349 systems

Distribution

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.

Lot, serial or model codes

Serial Numbers: 485886/SN11000007, 485062/SN11000009, 488169/SN11000011, 485061/SN11000012, 485059/SN11000013, 485060/SN11000015, 489089/SN11000016, 489616/SN11000033, 490027/SN11000034, 489694/SN11000035, 489695/SN11000036, 489696/SN11000037, 490221/SN11000039, 489088/SN11000040, 493566/SN11000047, 493565/SN11000048, 494867/SN11000051, 494941/SN11000052, 492417/SN11000053, 494456/SN11000055, 494865/SN11000056, 494864/SN11000060, 495286/SN11000061, 494866/SN11000062, 494464/SN11000065, 497570/SN11000066, 488171/SN11000068, 494060/SN11000070, 494061/SN11000071, 494062/SN11000072, 494063/SN11000073, 494064/SN11000074, 494065/SN11000075, 497715/SN11000080, 496446/SN11000082, 496387/SN12000003, 495938/SN12000007, 495939/SN12000008, 493364/SN12000022, 493462/SN12000023, 501028/SN12000026, 500739/SN12000027, 500740/SN12000028, 502424/SN12000034, 503143/SN12000036, 503142/SN12000037, 503141/SN12000038, 503144/SN12000039, 503541/SN12000040, 500466/SN12000045, 502721/SN12000047, 505077/SN12000048, 506626/SN12000051, 507607/SN12000054, 507906/SN12000055, 508342/SN12000057, 500468/SN12000058, 496401/SN12000059, 500467/SN12000060, 508838/SN12000061, 508532/SN12000062, 504450/SN12000064, 509718/SN12000068, 510607/SN12000072, 512160/SN12000077, 513477/SN12000080, 513478/SN12000081, 512892/SN12000082, 513848/SN12000084, 512887/SN12000085, 512888/SN12000086, 512890/SN12000087, 508699/SN12000088, 514462/SN12000089, 514461/SN12000090, 514104/SN12000091, 514103/SN12000092, 509062/SN12000107, 508783/SN12000108, 516891/SN12000110, 516896/SN12000111, 497572/SN12000112, 518135/SN12000118, 518342/SN12000119, 518343/SN12000120, 518344/SN12000121, 518345/SN12000122, 518346/SN12000123, 502025/SN12000124, 502026/SN12000125, 12000166, 519326/SN13000005, 519388/SN13000006, 519511/SN13000010, 519506/SN13000011, 519387/SN13000012, 519763/SN13000013, 519434/SN13000014, 520251/SN13000016, 520253/SN13000017, 519762/SN13000018, 520254/SN13000019, 520255/SN13000020, 520256/SN13000021, 520413/SN13000023, 520414/SN13000025, 520415/SN13000026, 520252/SN13000027, 520422/SN13000028, 520418/SN13000030, 520416/SN13000031, 520417/SN13000033, 522633/SN13000035, 522944/SN13000037, 523279/SN13000042, 523349/SN13000043, 13000046, 13000047, 13000048, 13000049, 13000053, 13000054, 13000055, 13000056, 13000057, 13000058, SN13000059, 13000060, SN13000061, SN13000062, SN13000063, 13000067, SN13000069, 13000070, 13000071, SN13000072, SN13000073, SN13000074, 13000075, 13000076, 13000077, 13000078, 13000079, SN13000080, SN13000082, SN13000083, SN13000084, 13000085, SN13000087, SN13000089, SN13000090, SN13000091, 13000092, 13000093, 13000094, SN13000099, SN13000100, SN13000101, SN13000102, SN13000103, SN13000104, SN13000106, SN13000107, 13000109, SN13000112, SN13000113, 519598/SN13000118, 519599/SN13000119, 519600/SN13000120, SN13000125, 13000127, 13000139, 13000140, 13000141, 13000143, 13000144, 13000145, SN13000146, SN13000147, SN13000148, SN13000149, SN13000153, SN13000154, SN13000157, SN7369686, SN13000159, SN13000160, SN13000163, SN13000164, SN13000165, 13000167, 13000168, 13000169, SN13000170, SN13000174, SN13000176, SN13000177, SN13000179, SN13000180, SN13000181, SN13000182, SN13000183, SN13000185, 13000196, 13000199, 13000200, 13000201, 13000202, 13000203, 13000204, 13000205, SN13000206, 14000004, 14000005, 14000006, 14000008, 14000009, 14000010, 14000011, 14000013, 14000014, 14000015, 14000016, 14000017, 14000019, 14000022, 14000024, 14000026, 14000028, 14000029, 14000031, 14000032, 14000033, 14000034, 14000037, 14000038, 14000041, 14000043, 14000046, 14000047, 14000048, 14000049, 14000050, 14000051, 14000052, SN14000061, 14000069, SN14000072, 14000075, 14000077, 14000078, 14000079, 14000080, 14000081, 14000082, 14000084, 14000086, 14000087, 14000088, 14000089, SN14000096, SN14000097, SN14000098, SN14000099, SN14000100, 14000092, 14000083, 14000085, 14000103, 14000106, 14000083, 14000109, 14000112, 14000116, 14000119, 14000118, 14000120, 14000121, 14000122, 14000124, SN14000128, 14000127, 14000126, SN14000130, 14000134, 14000135, 14000138, 14000139, SN15000002, 14100044, 14100045, 14100053, 14100054, 14100085, 14100086, 14100087, 14100088, 14100090, 14100094, 14100095, 14100097, 14100101, 14100104, 14100105, 14100109, 14100111, 14100117, 14100126, 14100127, 14100128, SN14100046, 15100019, 15100023, SN14100047, SN14100055, SN14100071, SN14100072, SN14100073, SN14100074, SN14100075, 15100028, 15100034, 15100035, 15100036, 15100039, 15100040, 15100041, 15100042, 15100047, 15100048, 15100050, 15100071, 15100084, 15100087, 15100088, 15100089, 15100091, 15100092, 15100093, 15100094, 15100095, 15100097, 15100098, 15100101, 15100103, 15100104, SN15100020, SN15100009, SN15100016, SN15100010, SN15100011, SN15100013 and SN15100018.

510(k) numbers

["K111725"]

PMA numbers

not on file

Product code

IZL

Firm FEI

3002495042

Firm city

Algete

Firm state

not on file

Firm country

Spain

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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