Z-3020-2011

CIVCO SBRT System, REF MTSBRT001, containing CIVCO Pro-Lok Platform, REF MTSBRT002. Firm name on label is...

Name: Z-3020-2011 CIVCO SBRT System, REF MTSBRT001, containing CIVCO Pro-Lok Platform, REF MTSBRT002. Firm name on label is...
Creator: Civco Medical Instruments Inc
Published: 2010-12-30
License: https://open.fda.gov/license/

CIVCO Medical Instruments Co., Inc. / initiated 2010-12-30 / Terminated / root cause: manufacturing process

FDA source

Civco Medical Instruments Inc began a recall of CIVCO SBRT System, REF MTSBRT001, containing CIVCO Pro-Lok Platform, REF MTSBRT002. Firm name on label is CIVCO, Orange City, Iowa Product Usage: The recalled... on 2010-12-30. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-3020-2011
Status: Terminated
Initiated: 2010-12-30
Posted: 2011-08-15
Terminated: 2013-06-28
Recalling firm: CIVCO Medical Instruments Co., Inc.
Product: CIVCO SBRT System, REF MTSBRT001, containing CIVCO Pro-Lok Platform, REF MTSBRT002. Firm name on label is CIVCO, Orange City, Iowa Product Usage: The recalled product is intended to support and aid in positioning a patient during radiologic and other medical procedures.
Product code: IXQ Table, Radiographic, Stationary Top
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: 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.
Quantity in commerce: 65 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 Turkey.
Product codes and lots: M061240, M061420, M064140, M064150, M064160, M064170, M064180, M064190, M064200, M064210, M064220, M064230, M070640, M070650, M070660, M072030, M104700, M104710, M104720, M104740, M110410, M110420, M110450, M110460, M115610, M128630, M128660, M128680, M128690, M137590, M148640, M148660, M148690, M148700, M165740, M177850, M177880, M226800, M226810, M226820, M226830, M226840, M239320, M239330 and M256660

Product code IXQ

K973842Class IICarbon Fiber Conformal Couch TopMedtec, Inc. / cleared 1997-12-05

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)