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Open, Classified

INFX-8000C XGCP-930AA TABLE SIDE CONSOLE, INFX-8000C XGCP-930BA TABLE SIDE CONSOLE

FDA Recall Z-2392-2023 · Posted 2023-08-11

Recall StatusOpen, Classified
Product CodeOWB
Date Initiated2023-06-22
Product Quantity12

Reason for Recall

The C-arm, used to set the position and angle of the x-ray exposure field, may not function due to the tableside console PWB, which needs replacement. There may be a delay in the procedure, but procedures can continue using the operators console, the switches on the back of the column, switches on the side of the flat panel detector, and the emergency stop will continue to function normally.

Firm Action

On 6/22/23 correction notices were emailed to customers who were advised of the following: If the table side control does not function then the procedure can continue using the operators console in the operator room, the switches on the back of the column and the switches on the side of the flat panel detector. The emergency stop should not be affected and will continue to function normally. Neither manual operation or auto positioning of the C-arm can be performed on the console during procedure, and the C-arm will not operate. A firm representative will contact you to schedule a time to replace the PWB on the console. Complete and return the customer reply form to [email protected] For questions, contact the InTouch team at [email protected] or your service representative at 800.521.1968

Root Cause

Nonconforming Material/Component

Distribution Pattern

US Nationwide Distribution: NY, CO, IL, CA, MD, MN, WA

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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