Z-2116-2010

PowerPark is an accessory to the V or H Universal Stand and comprised of two parts: the stand mounted...

Name: Z-2116-2010 PowerPark is an accessory to the V or H Universal Stand and comprised of two parts: the stand mounted...
Creator: Sonosite, Inc.
Published: 2010-05-27
License: https://open.fda.gov/license/

FUJIFILM SonoSite,Inc. / initiated 2010-05-27 / Terminated / root cause: manufacturing process

FDA source

Sonosite, Inc. began a recall of 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... on 2010-05-27. The reason FDA records is "PowerPark system has a potential for loss of power at the corresponding wall outlet and/or circuit due to poor alignment". 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-2116-2010
Status: Terminated
Initiated: 2010-05-27
Posted: 2010-08-02
Terminated: 2011-04-18
Recalling firm: FUJIFILM SonoSite,Inc.
Product: 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".
Product code: IYN System, Imaging, Pulsed Doppler, Ultrasonic
Reason for recall: PowerPark system has a potential for loss of power at the corresponding wall outlet and/or circuit due to poor alignment.
Root cause tag: manufacturing process
FDA 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 [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.
Quantity in commerce: 26
Distribution: Worldwide Distribution -- USA, including states of GA, NM, PA, TX, VA, and WA and country of Australia.
Product codes and lots: Serial numbers for the Stand Mounted Assembly (P12822): 03J5RJ; 03J5G2; 03J5RX; 03J5GC; 03J5FN; 03J5RH; 03J5BL; 03J5FF; 03J5D1; 03J5CV; 03J5D0; 03J5GN; 03J4RB; 03J5D4; 03J5G9; 03HPVK; 03J5T3; 03HPVF; 03J4RD; 03J5D3; 03J5G1; 03J5FD; 03J5G5; 03J5CZ; 03J4RC; and 03J4RG. Serial numbers for the Docking Assembly (P12834): 03J4R0; 03J4R1; 03J5CY; 03J4R4; 03J520; 03J5FK; 03J5G7; 03J5G8; 03J51R; 03J5BF; 03J5BH; 03J4R6; 03J5GJ; 03J5GG; 03J5FL; 3J4RX; 03J5GK; 03J0GR; 03J5RR; 03J5G6; 03J5RC; 03J5FJ; 03J5G5; 03J5RV; 03J5GH; and 03J5RF.

Product code IYN

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)