PowerPark is an accessory to the V or H Universal Stand and comprised of two parts: the stand mounted assembly (P12822)
FDA device recall Z-2116-2010 · posted 2010-08-02 · Terminated
Recall details
- Recalling firm
- Sonosite, Inc.
- Reason for recall
- PowerPark system has a potential for loss of power at the corresponding wall outlet and/or circuit due to poor alignment.
- Action taken
- 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 Applications Specialist to schedule an appointment to retrieve the device and deliver a refund.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- IYN
- Quantity affected
- 26
- Distribution
- Worldwide Distribution -- USA, including states of GA, NM, PA, TX, VA, and WA and country of Australia.
- Date initiated
- 2010-05-27
- Date posted
- 2010-08-02
- Date terminated
- 2011-04-18
- Location
- Bothell, WA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SONOSITE NANOMAXX SERIES ULTRASOUND SYSTEM (K092058) | Sonosite,Inc. | 2009-10-02 |
| SONOSITE MAXX SERIES ULTRASOUND SYSTEM (K082098) | Sonosite,Inc. | 2008-08-25 |
| SONOSITE MICROMAXX DIAGNOSTIC ULTRASOUND SYSTEM (C3 SERIES) (K053069) | Sonosite,Inc. | 2005-11-16 |