SEDECAL SA: MobileDiagnost wDR, Model numbers 712001, 712002, 712004, 712006, and 712007

Recall number

Z-1083-2024

Recalling firm

SEDECAL SA

Product

MobileDiagnost wDR, Model numbers 712001, 712002, 712004, 712006, and 712007

Status

Open, Classified

Initiated

2021-10-14

Posted

2024-02-14

Terminated

not on file

Reason

While cleaning or disinfecting the system, if the process is not followed as described in the manual and excessive liquid is used or sprayed directly on the system, it could cause a short circuit of the fine positioning control button. This would result in the system moving on its own in a very slow speed forward circular motion.

Root cause

Use error

Action

The distributor in the U.S., Philips, issued letters to consignees dated 05-October-2021 and flagged "IMPORTANT PRODUCT NOTICE" via certified mail on 10/14/2021. The letter explained the problem and under what circumstances it can occur, how to identify whether the consignee has the affected product, and the actions that can be taken to minimize the effect of the problem. The consignee is to: (1) Circulate this notice to all users of the device so that they are aware of the issues; (2) Attach this notice as an addendum to the MobileDiagnost wDR IFU for ease of reference; (3) If unintended motion occurs, press Emergency Stop button to prevent further movement, allow unit to dry and once dry, the system will move as intended, and if the problem persists, contact their local Philips representative and reference the FCO number provided; (4) During cleaning, do not use wet wipes, liquids, and do not spray disinfectants directly on the buttons since this may cause electrical short circuits or metal corrosion, and follow the cleaning instructions provided in the Maintenance, Cleaning and Disposal section of the instruction for use. For actions planned by Philips to correct the problem, the notice says Philips is providing this customer letter containing guidance and alternative process steps to mitigate potential issues. An Important Product Notice Acknowledgement Form was attached for completion and return to Philips no later than 30 days from receipt. The form is to confirm receipt of the Important Product Notice, understanding of the issue, and required actions to be taken.

Quantity

851 devices

Distribution

US Nationwide distribution. There was government distribution but no military distribution.

Lot, serial or model codes

Model 712001 - UDI-DI 00884838028586, all serial numbers; Model 712002 - UDI-DI 00884838082373, all serial numbers; Model 712004 - UDI-DI 08436046002173, all serial numbers; Model 712006 - UDI-DI 00884838091504, serial numbers: SN20410556 and SN21410184; Model 712007 - UDI-DI)08436046002357, serial numbers: 26, 27, 19410038, 19410044, 19410046, 21410261, 21410266, 21410280, 21410288, 21410290, 21410291, 21410293, 21410294, 21410339, 21410340, 21410341, 21410342, 21410345, 22410022, 22410023, SN0410157, SN1410049, SN19410034, SN19410035, SN19410036, SN19410037, SN19410071, SN19410092, SN19410093, SN19410094, SN19410097, SN19410098, SN19410099, SN19410100, SN19410101, SN19410102, SN19410115, SN19410116, SN19410123, SN19410127, SN19410129, SN19410135, SN19410136, SN19410137, SN20410029, SN20410030, SN20410032, SN20410033, SN20410034, SN20410044, SN20410045, SN20410049, SN20410060, SN20410063, SN20410064, SN20410065, SN20410066, SN20410071, SN20410072, SN20410073, SN20410074, SN20410081, SN20410082, SN20410083, SN20410084, SN20410093, SN20410094, SN20410095, SN20410096, SN20410097, SN20410115, SN20410116, SN20410117, SN20410118, SN20410119, SN20410120, SN20410154, SN20410171, SN20410172, SN20410202, SN20410218, SN20410219, SN20410242, SN20410260, SN20410261, SN20410279, SN20410280, SN20410288, SN20410289, SN20410290, SN20410291, SN20410298, SN20410299, SN20410300, SN20410313, SN20410321, SN20410334, SN20410360, SN20410367, SN20410373, SN20410395, SN20410396, SN20410428, SN20410472, SN20410473, SN20410482, SN20410555, SN20410556, SN20410557, SN20410566, SN20410567, SN20410570, SN21410017, SN21410034, SN21410035, SN21410048, SN21410060, SN21410061, SN21410062, SN21410081, SN21410093, SN21410094, SN21410094, SN21410099, SN21410103, SN21410104, SN21410105, SN21410117, SN21410118, SN21410119, SN21410130, SN21410131, SN21410132, SN21410133, SN21410149, SN21410150, SN21410153, SN21410154, SN21410155, SN21410169, SN21410170, SN21410171, SN21410172, SN21410187, SN21410188, SN21410189, SN21410190, SN21410200, SN21410201, SN21410203, SN21410204, SN21410205, SN21410206, SN21410207, SN21410208, SN21410212, SN21410213, SN21410214, SN21410232, SNZY20410009, SNZY20410011, SNZY20410014, and SNZY204110015.

510(k) numbers

["K111725","K141895","K191813"]

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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