Philips Ultrasound, Inc. Sparq, Diagnostic Ultrasound System, REF 795090, 100-240V -, 50/60 Hz, 500 VA, CE2797, Rx Only,
- Company
- Philips Ultrasound, Inc.
- Recall Initiated
- August 19, 2021
- Terminated
- September 6, 2024
- Recall Number
- Z-0070-2022
- Quantity
- 34 units
- Firm Location
- Bothell, WA
Reason for Recall
Battery system data issue with the ultrasound system can intermittently cause a system shutdown, regardless of actual battery state or application of alternating current power.
Distribution
Worldwide distribution - US Nationwide distribution in the states of CA, MA, MD, MI, MS, NC, NY, OH, VA, WA and the countries of Australia, Portugal, Netherlands, Canada, Netherlands, Germany.
Lot / Code Info
Affected Serial Numbers/UDI numbers: USD1410130 /N/A, US12110905 /(01)00884838097971(21)US12110905, US12110906 /(01)00884838097971(21)US12110906, US12111049 /(01)00884838097971(21)US12111049, US31310191 /N/A, US31511242 /N/A, US32111072 /(01)00884838097971(21)US32111072, US41210049 /N/A, US42111774 /(01)00884838097971(21)US42111774, US51210186 /N/A, US62011642 /(01)00884838028098(21)US62011642, US71810505 /(01)00884838028098(21)US71810505, US72011713 /(01)00884838028098(21)US72011713, US72011714 /(01)00884838028098(21)US72011714, US82010111 /(01)00884838028098(21)US82010111, US91410757 /N/A, US92010327 /(01)00884838028098(21)US92010327, US92010512 /(01)00884838028098(21)US92010512, USD2011313 /(01)00884838097971(21)USD2011313, USD2011314 /(01)00884838097971(21)USD2011314, USD2011362 /(01)00884838097971(21)USD2011362, USD2011363 /(01)00884838097971(21)USD2011363, USD2011480 /(01)00884838097971(21)USD2011480, USD2011481 /(01)00884838097971(21)USD2011481, USD2011482 /(01)00884838097971(21)USD2011482, USD2011483 /(01)00884838097971(21)USD2011483, USD2011578 /(01)00884838097971(21)USD2011578, USD2011622 /(01)00884838097971(21)USD2011622, USD2011623 /(01)00884838097971(21)USD2011623, USN1510828 /N/A, USN2011691 /(01)00884838097971(21)USN2011691, USO1210225 /N/A, USO2011257 /(01)00884838097971(21)USO2011257, USO2012052/ (01)00884838097971(21)USO2012052
Root Cause
Software design
Action Taken
On August 24, 2021, Philips issued "Urgent Medical device Correction" notification to affected consignees. The customer communication was distributed via: USPS Certified Mail In addition to informing consignees about the recall, Philips requested consignees take the following actions: Instructions for how to determine the software version of your Ultrasound system: 1. Power up the system and allow it to complete the boot sequence, 2. Press the Wrench icon on the upper right side of the control panel, 3. Press the Service button on the bottom left corner, 4. Under System Management, Press System Information, 5. The software version is listed in the Software Information Section. 4. Describe the actions that should be taken by the customer / user in order to prevent risks for patients or users A. If this shutdown occurs, Philips recommends that the system be put back on AC power and restarted. The system will be fully functional upon restart. However, restarting the system will not prevent the possibility of the issue reoccurring. B. Please complete and return the attached form to Philips promptly and no later than 30 days from receipt (via email: ultrasound.corrections@philips.com, or fax: 1-833-512-7756). 5. Describe the actions planned by Philips Ultrasound to correct the problem A Philips Field Service Engineer will contact you to schedule a software update to permanently resolve the issue (reference FCO79500550). 6. This notice has been reported to the appropriate Regulatory Agencies. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, or by regular mail, or by fax. 7. Please be assured that maintaining a high level of safety and quality is our highest priority. If you need any further information or support concerning this issue, please contact your local Philips representative: 1-800-722-9377 and reference FCO79500550.