Volcano Corporation: Philips 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.

Recall number

Z-0674-2020

Recalling firm

Volcano Corporation

Product

Philips 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.

Status

Terminated

Initiated

2018-11-07

Posted

2019-12-12

Terminated

2022-07-14

Reason

Interoperability issue that affects certain systems that use the recalled software when it is connected to specific Hemodynamic Systems (HMS).

Root cause

Employee error

Action

The 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

3,667 units with software

Distribution

Distribution 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.

Lot, serial or model codes

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)

510(k) numbers

["K170133"]

PMA numbers

not on file

Product code

IYO

Firm FEI

2939520

Firm city

Rancho Cordova

Firm state

CA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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