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Model Number SM-40HF-B-D-C recallZ-0277-2026 · Sedecal SA · initiated Jun 10, 2025

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

Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.

FDA root cause category: Device Design

What the company is doing

Sedecal emailed their distributors on 06/10/2025 to remind them the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning. on 09/19/2025 the firm issued an Important Safety Notice to its direct consignees via email. This notice initiates Phase 2 of the recall strategy expanding the scope and providing information on stickers to cover gaps around the fine positioning control buttons and a DMC software update that stops unit movement if triggered by a short cicuit or prolonged button press with instructions. Consignees will be contacted by a Sedecal Customer support Service to coordinate the shipment of the necessary conversion kits (quantity and delivery address) to allow upgrading the affected units.

Recall details

Recall number
Z-0277-2026
Status
Open, Classified
Initiated by the company
Jun 10, 2025
Posted by the FDA
Oct 23, 2025
Recalling firm
Sedecal SA
Quantity
142 units
Product code
IZL
FDA submissions
K090322
Distribution
US: CA, IL, and NJ

Product description

Model Number SM-40HF-B-D-C; 40KW, Mobile X-ray system

Code information (models, lots, serial numbers)

Show the full code information (1k characters)

UDI/DI 08436046001510, Serial Numbers: G65281, G60407, G65682, G64582, G64789, G70752, G65384, G65418, G67250, G68470, G70521, G70524, G70913, G70914, G65166, G63507, G64205, G64842, G71447, G65175, G65382, G64793, G64798, G40226, G72434, G65554, G67230, G37280, G65174, G65558, 15033R, G64271, G64713, G64849, G65168, G71272, G71309, G65284, G72955, G65043, G70919, G72429, G72789, G70928, G72776, G72766, G63409, G63418, G64893, G66907, G65588, G65402, G73096, G73131, G71269, G71750, G71762, G71267, G71727, G71732, G71745, G71755, G71761, G66892, G65275, G70922, G73154, G64505, G65744, G73033, G73134, G64941, G63489, G65036, G64256, G72976, G73092, G73145, G64196, G64945, G72412, G73074, G65414, G71726, G71743, G64807, G66872, G67257, G40208, G64885, G38391, G39467, G39818, G65408, G70748, G37108, G6715, G67232, G71277, G71286, G64604, G37406, G40004, G63223, G63224, G63232, G61711, G71271, G71302, G72790, G64500, G65269, G65692, G65290, G65691, G66862, G65283, G64189, G70744, G64812, G70755, G65286, G65266, G72760, G66884, G64601, G71300, G67185, G63495, G64890, G72780, G64607, G63488, G63494, G71285 - NCR1161, G63501, G41245, G64797, G64819, G64855, G72803, G41213.

Devices named in this recall

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

Other devices under the same FDA submission

6 devices cleared under K090322 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 97075).

Sources and updates

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