Recall Z-0468-2015— Summit Industries Inc.

Name: FDA recall Z-0468-2015
Creator: U.S. Food and Drug Administration
Published: 2014-10-28

Class II · Terminated

Class II FDA medical device recall by Summit Industries Inc., initiated 2014-10-28, terminated 2015-05-21. It names one FDA 510(k) clearance: K850198. Product: The J700 Floor Mounted Tube Stand (FMTS) is intended to support and position the diagnostic x-ray tube housing assembly for a medical radiographic procedure. The product consists of a vertical column (with counterbalanced vertical carriage, counterweight and pulley system), horizontal floor car and a floor mounted track to ride on.. Reason: The welds on J700 tube stands may be insufficient resulting in tube stand breakage, damage to the X-Ray machine, and/or patient or healthcare provider injury..

Recalling firm: Summit Industries Inc.
Classification: Class II
Status: Terminated
Initiated: 2014-10-28
Terminated: 2015-05-21
Firm location: Chicago, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K850198 — FLOOR TO WALL OR FLOOR TO CEILING TUBESTAND; RADIOGSummit Industries, Inc.·cleared 1985-05-14

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

The J700 Floor Mounted Tube Stand (FMTS) is intended to support and position the diagnostic x-ray tube housing assembly for a medical radiographic procedure. The product consists of a vertical column (with counterbalanced vertical carriage, counterweight and pulley system), horizontal floor car and a floor mounted track to ride on.

Reason for recall

The welds on J700 tube stands may be insufficient resulting in tube stand breakage, damage to the X-Ray machine, and/or patient or healthcare provider injury.

Data sourced from openFDA. This site is unofficial and independent of the FDA.