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MobileDiagnost wDR, Model numbers 712001, 712002, 712004… recallZ-1083-2024 · Sedecal SA · initiated Oct 14, 2021

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Sedecal SA or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Use error

What the company is doing

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.

Recall details

Recall number
Z-1083-2024
Status
Open, Classified
Initiated by the company
Oct 14, 2021
Posted by the FDA
Feb 14, 2024
Recalling firm
Sedecal SA
Quantity
851 devices
Product code
IZL
FDA submissions
K141895, K191813, K111725
Distribution
US Nationwide distribution. There was government distribution but no military distribution.

Product description

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

Code information (models, lots, serial numbers)

Show the full code information (2k characters)

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.

Devices named in this recall

2 devices in the FDA device registry whose identifier appears in the recall's code information.

Sources and updates

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