Recall Z-3021-2011 ยท IXQ Table, Radiographic, Stationary Top
Civco Medical Instruments Inc
CIVCO SBRT System, REF MTSBRT001L, 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.
| Date | Aug 15, 2011 (initiated Dec 30, 2010) |
| Status | Terminated |
| Reason | 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 | 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 fir |
| Quantity | 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 Turkey. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K973842 | CARBON FIBER CONFORMAL COUCH TOP Medtec, Inc., Dec 5, 1997 |