The J700 Floor Mounted Tube Stand (FMTS) is intended to support and position the diagnostic x-ray tube housing assembly

FDA device recall Z-0468-2015 · posted 2014-12-01 · Terminated

Recall details

Recalling firm

Summit Industries Inc.

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.

Action taken

Summit Industries sent an Urgent Medical Device Recall letter dated October 27, 2014, to all direct accounts (distributors). The letters included instructions for distributors to: 1) make every effort to locate the affected devices; 2) replace and return the defective parts; 3) contact the end user for any defective device(s) that were installed and determine if the affected device(s) is/are in service; 4) if the device(s) is/are still in service, deliver a copy of the "End User Letter", immobilize the tube arm, and place the REMOVE FROM SERVICE sticker on the device; 5) complete and return the attached questionnaire for a no-charge purchase order for the necessary replacement parts; and, 5) inform the end user that new replacement pats will be installed as soon as possible. Distributors with questions can contact Summit Industries at 800-729-9729 (Monday - Friday, 7:00 AM - 3:45 PM CST). The Urgent Medical Device Recall letter dated October 27, 2014, to end users advised them of the recall and the steps that Summit Industries and their distributor would be taking to correct the issue.

Root cause

Process control

Status

Terminated

Product code

IYB

Quantity affected

32

Distribution

US Distribution including the states of: AZ, CO, IL, KY, LA, NE, NY, OH, PA, TN, TX, VA, WA and WV.

Date initiated

2014-10-28

Date posted

2014-12-01

Date terminated

2015-05-21

Location

Chicago, IL

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