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 part: "SonoSite Ltd...21919 30th Drive SE... Bothell, WA 98021, USA".
FDA Recall Z-2116-2010 · Posted 2010-08-02
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Recalling FirmSonosite, Inc.
Recall StatusTerminated
Product CodeIYN
Date Initiated2010-05-27
Date Terminated2011-04-18
Product Quantity26
Reason for Recall
PowerPark system has a potential for loss of power at the corresponding wall outlet and/or circuit due to poor alignment.
Firm 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 [email protected] 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 Applications Specialist to schedule an appointment to retrieve the device and deliver a refund.
Root Cause
Nonconforming Material/Component
Distribution Pattern
Worldwide Distribution -- USA, including states of GA, NM, PA, TX, VA, and WA and country of Australia.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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