Philips Volcano FFR software used in the following systems connected to the McKesson, Schwarzer, and some Philips Xper H

FDA device recall Z-0674-2020 · posted 2019-12-12 · Terminated

Recall details

Recalling firm

Volcano Corporation

Reason for recall

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

Action taken

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

Root cause

Employee error

Status

Terminated

Product code

IYO

Quantity affected

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 R

Date initiated

2018-11-07

Date posted

2019-12-12

Date terminated

2022-07-14

Location

Rancho Cordova, CA

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