Recall Z-3082-2017 ยท KXH Cradle, Patient, Radiologic
Med Tec Inc
CIVCO Arm Support, REF 106015, distributed as: (a) Rigid Arm Support, Standard, Set Red (PN: 106015) (b) Rigid Adj. Arm Support, Set (PN: 106020) (c) PSR2-CR-DLR-2P Posirest-2 (PN: 106521) (d) PB2-BLR Posiboard-2 (PN: 109030) The Rigid Arm Supports are utilized on the Posibboard2 and Posirest assemblies, which are intended to position the patients upper extremities during breast and lung
| Date | Aug 10, 2017 |
| Status | Terminated |
| Reason | Rigid Arm Supports (PN: 106015 and 106047), which were used as part of the Posiboard-2 and Posirest, and were distributed as PN: 106015, 106047, 106521, 106522, 109030, and 109040 between Ocotober 2009 and July 2012 may have a height difference of approximately 17mm. |
| Root cause | Other |
| Action | CIVCO sent an Urgent: Field Action Notice- Customer Communication letter dated July 20th, 2017. The field action notification letter was sent on August 10, 2017, by email requesting the consignee review their inventory and contact their sales representative for product replacement. Enclosed please find a notification letter which is required to be sent to all customers who received this product. Please contact your Insides Sales Representative concerning replacement instructions if you have any questions. You may reach your representative by calling CIVCO Radiotherapy, at 712-737-8688 |
| Quantity | 101 units |
| Distribution | Worldwide Distribution - US Distribution to the states of : MI, IL and TX., and to the countries of : Greece, Australia, Czech Republic, Hungary, Norway, Brazil, Italy, Switzerland ,UK, Austria, Slovenia, Croatia, Poland, Germany, Japan, France, Netherland, Sri Lanka, Pakistan, Bangladesh, and Isr |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.