Recall Z-2116-2010 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
Sonosite, Inc.
PowerPark is an accessory to the V or H Universal Stand and comprised of two parts: the stand mounted assembly (P12822) and a docking assembly (P12834). The stand mounted assembly is mounted to the V or H Universal stand and the docking assembly is plugged into a wall circuit. It provides a docking and charging station for the V and H Universal Stands. The product marketing brochure labeled in
| Date | Aug 2, 2010 (initiated May 27, 2010) |
| Status | Terminated |
| Reason | PowerPark system has a potential for loss of power at the corresponding wall outlet and/or circuit due to poor alignment. |
| Root cause | Nonconforming Material/Component |
| Action | On 05/27/10, SonoSite began contacting their consignees by telephone. On 06/01/10, SonoSite sent out the URGENT-MEDICAL DEVICE RECALL letter to their consignees. The letter describes the recall product as SonoSite PowerPark. Customers should call the Technical Support at 1-877-657-8118 or e-mail to service@sonosite.com for any questions regarding the recall. The letter instructs consignees to stop using the PowerPark immediately and return the product back to SonoSite in exchange for a full refund. The consignees will be contacted by the firm's Sales Representative and/or Clinical Applic |
| Quantity | 26 |
| Distribution | Worldwide Distribution -- USA, including states of GA, NM, PA, TX, VA, and WA and country of Australia. |
| FDA record | Open on fda.gov |