DRX-Revolution Mobile X-Ray System, MODEL DRXR-1, Service Code 1243, Catalog Number 1060177 (China) and 1019397 (all oth

FDA device recall Z-0800-2015 · posted 2014-12-16 · Terminated

Recall details

Recalling firm

Carestream Health Inc

Reason for recall

While servicing a unit at a customer site, a field engineer discovered a broken bolt from the carriage assembly. Carestream has identified an issue related to the DRX-Revolution Mobile X-Ray System in which bolts that secure the x-ray tube assembly/boom to the device mounting block may break. It has been determined that this issue is a result of an improperly assembled part which holds the x-ray

Action taken

The firm, Carestream, sent an "URGENT MEDICAL DEVICE RECALL" letter dated 11/20/2014 to US Consignees/customers via Certified Mail on 11/25/2014. Foreign accounts will be notified as soon as possible. The letter described the product, problem and actions to taken. The customers were instructed if they observe a loosened boom to follow the procedure for turning the system off; stop using the device and contact Carestream Customer Care Center in the U.S. at 1-800-328-2910, available 7 days per week on a 24 hour basis; Outside of the U.S., call your local Service support number. Carestream Health Service representative will contact all customers to schedule a visit to inspect the DRX-Revolution Mobile X-Ray System. If a repair is required it will be completed by a Carestream Field Engineer. If you have any questions, contact the Regulatory Affairs Manager at 585-627-8230 or Carestream Customer Care Center in the U.S. at 1-800-328-2910, available 7 days per week on a 24 hour basis.

Root cause

Device Design

Status

Terminated

Product code

IZL

Quantity affected

629 units (Domestic: 358 units; Foreign: 271 units)

Distribution

Worldwide Distribution: US (nationwide) and countries of: AUSTRALIA, BELGIUM, CANADA, CHILE, CHINA, DENMARK, FINLAND, FRANCE, GERMANY, ITALY, JAPAN, KOREA, KUWAIT, MALAYSIA, NETHERLANDS, NEW ZEALAND,

Date initiated

2014-11-25

Date posted

2014-12-16

Date terminated

2016-06-06

Location

Rochester, NY

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