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Alphenix Models recallZ-3014-2026 · Canon Medical System, USA, INC. · initiated Aug 4, 2026

Class II Open, Classified All recalls posted in August 2026

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 Canon Medical System, USA, INC. 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

Due to the fixing screws of ceiling movement gear in ceiling suspended arm that are part of the X-ray interventional systems may become loose.

FDA root cause category: Process control

What the company is doing

On 08/04/2026, an "URGENT: MEDICAL DEVICE CORRECTION" letter was sent via email informing customers that, It has been found there is a possibility that the fixing screws of ceiling movement gear in ceiling suspended arm that are part of the X-ray interventional systems may become loose. Indications that the screws have loosened are abnormal noises and sensor errors from the ceiling mounted C-arm. Customers are instructed to: Should the suspended device make an abnormal noise, or a sensor error is displayed before the corrective action is implemented on your system, please stop using the device and call your local Canon Service Team. Additionally, it is strongly requested that you share the contents of this letter with all users as well as clinical engineering or biomedical group at your facility. A representative of Canon Medical Systems USA will contact customers to schedule a time to check for the tightening and proper attachment of the fixing screws to correct this issue your system(s). For Questions - contact your service representative contact the InTouch team at [email protected].

Recall details

Recall number
Z-3014-2026
Recall class
Class II
Status
Open, Classified
Initiated by the company
Aug 4, 2026
Posted by the FDA
Aug 25, 2026
Recalling firm
Canon Medical System, USA, INC.
Quantity
10 systems
Product code
OWB
FDA submissions
K182415, K203551, K210900
Distribution
U.S. Nationwide distribution in the states of CA, GA, MN, NC, NV, PA, OH, and TX.

Product description

Alphenix Models INFX-8000C INFX-8000F INFX-8000V This device is a digital radiography/fluoroscopy system used in a diagnostic and interventional angiography configuration. The system is indicated for use in diagnostic and angiographic procedures for blood vessels in the heart, brain, abdomen and lower extremities.

Code information (models, lots, serial numbers)

Show the full code information (1k characters)

Model Number: INFX-8000C/B3 UDI code: Pending SID Number:30101165 Serial Number: B3E2422005 Model Number: INFX-8000F/SG UDI code: Pending SID Number: 30093711 Serial Number: SGC2412001 Model Number: INFX-8000V/SZ UDI code: Pending SID Number: 30029686 Serial Number: SZA2422001 SID Number: 79000002 Serial Number:SZA2442004 Model Number: INFX-8000V/SX UDI code: Pending SID Number: 30049491 Serial Number: SXA2432001 SID Number: 30100053 Serial Number: SXA2432002 Model Number: INFX-8000V/B9 UDI code: Pending SID Number: 30059175 Serial Number: B9F2412001 Model Number: INFX-8000V/ST UDI code: Pending SID Number: 30059180 Serial Number: STA2412001 Model Number: INFX-8000V/SZ UDI code: Pending SID Number: 30095017 Serial Number: SZA2432003 SID Number: 30097052 Serial Number: SZA2422002

Other devices under the same FDA submission

2 devices cleared under K182415, K203551, K210900 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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