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U.S. Department of Health and Human Services

Class 2 Device Recall Philips Volcano V2.5 FFR/IFR software

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 Class 2 Device Recall Philips Volcano V2.5 FFR/IFR softwaresee related information
Date Initiated by FirmNovember 07, 2018
Date PostedDecember 12, 2019
Recall Status1 Terminated 3 on July 14, 2022
Recall NumberZ-0674-2020
Recall Event ID 83919
510(K)NumberK170133 
Product Classification System, imaging, pulsed echo, ultrasonic - Product Code IYO
ProductPhilips Volcano FFR software used in the following systems connected to the McKesson, Schwarzer, and some Philips Xper Hemodynamic Systems (HMS): (1) Volcano Imaging System s5i, Part #807400001; (2) s5ix Imaging System with s5iz PC Workstation Refurbished, Part#807400001 R and 807401200; (3) s5i Imaging System, Part#806300003; (4) s5i Imaging System, Part#5322466; (5) s5x Imaging System, Part#807300001; (6) s5x Imaging System Refurbished, Pat#807300001 R; (7) s5 Imaging System Refurbished, Part#804200001 R; (8) CORE Mobile Imaging System (120V), Part #400-0100.01; (9) CORE Mobile Imaging System Refurbished, Part #400-0100.01-R; (10) CORE Mobile Imaging System (240V), Part #400-0100.07; (11) CORE Mobile Imaging System Refurbished, Part #400-0100.07-R; (12) CORE Mobile Imaging System (100V), Part #400-0100.08; (13) CORE Mobile Imaging System Refurbished, Part #400-0100.08-R; and (14) CORE Imaging System, Part #400-0100.02; (15) CORE Integrated Imaging System Refurbished, Part#400 0100.02 R.
Code Information FFR V2.5 Software Kit, Catalog 4536-010-57091 (Legacy 435-0602.48) and FFR V2.5 Update Installation Disk, Catalog 4536-010-52781 (Legacy 435-0100.98)
Recalling Firm/
Manufacturer		 Volcano Corporation
2870 Kilgore Rd
Rancho Cordova CA 95670-6133
For Additional Information ContactMs. Portia Peng
916-281-2900
Manufacturer Reason
for Recall		Interoperability issue that affects certain systems that use the recalled software when it is connected to specific Hemodynamic Systems (HMS).
FDA Determined
Cause 2		Employee error
ActionThe recalling firm issued letters dated 10/26/2018 during the week of 11/7/2018. The letters explain how to detect any potential interoperability and provide details of the impact to the system performance. The letters will be sent via proof of delivery. Field Service Engineers will visit each site to install the software update. Urgent Medical Device Field Action notices, dated 04/27/2020, were mailed to customers during the week of 04/27/2020. Customers informed of the following: If the calibrated device Pa values have a misalignment greater than plus/minus 3mm Hg, contact Technical Support so that the system can be corrected. Additionally, a software update has been developed which will resolve the interoperability issue. The Technical support team will deploy the software update on each impacted system to address the interoperability issue described above. Please ensure that a copy of this letter is provided to all personnel within your organization who handle this device. Customers with additional questions are encouraged to call: 18002284728, Option 2, or email: igtd.remotesupport@philips.com
Quantity in Commerce3,667 units with software
DistributionDistribution was nationwide. There was government/military distribution. Foreign distribution was made to Canada, Austria, Australia, Badajoz, Bahrain, Belgium, Brazil, Bulgaria, Chile, China, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, Iceland, India, Ireland, Israel, Italy, Jordan, Japan, Korea, Republic of, Lebanon, Lithuania, Malaysia, Malta, Mexico, Netherlands, New Zealand, Norway, Pakistan, Poland, Portugal, Romania, Russian Federation, Saudi Arabia, Serbia, Sierra Leone, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, and United Kingdom.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = IYO
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