CIVCO SBRT System, REF MTSBRT001L, containing CIVCO Pro-Lok Platform, REF MTSBRT002. Firm name on label is CIVCO, Orange

FDA device recall Z-3021-2011 · posted 2011-08-15 · Terminated

Recall details

Recalling firm

Civco Medical Instruments Inc

Reason for recall

Systems sold before December 2009 displayed a scale of 0-40cm going from left to right, while systems after December 2009 reversed this and were displayed as 40-0cm from left to right.

Action taken

CIVCO issued a "FIELD SAFETY NOTIFICATION" letter dated 12/20/2010 beginning 12/30/2010, via FedEx or UPS to distributors and customers. The notification identifies the affected device, problem, and field safety corrective action. The letter states that if customers have more than one system purchased from different time periods that they should examine their systems and assess if there is any mismatch. The recalling firm will rework the system to correct the difference and send it back to the customer. To take advantage of this correction customers are advised to contact the recalling firm within thirty days of receiving the safety notification. The letter includes a response form to be completed and returned as per instructions, to indicate that the notice has been read and understood by all operators of the equipment. The letter to distributors requested that a copy of the notification letter be forward to all customers who have received this component. For assistance contact your CIVCO insides sales representative by calling CIVCO Medical Solutions, Radiation Oncology, at 800-842-8688.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

IXQ

Quantity affected

49 systems

Distribution

Worldwide Distribution - USA ( nationwide) including the state of PA. and countries of: Canada, China, England, Israel, Italy, Japan, Korea, The Netherlands, Russia, Spain, Sweden, Switzerland and Tur

Date initiated

2010-12-30

Date posted

2011-08-15

Date terminated

2013-06-28

Location

Kalona, IA

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