Date Initiated by Firm | March 05, 2013 |
Date Posted | June 11, 2014 |
Recall Status1 |
Terminated 3 on May 17, 2017 |
Recall Number | Z-1783-2014 |
Recall Event ID |
64507 |
510(K)Number | K102495 |
Product Classification |
Monitor, Physiological, Patient (with arrhythmia detection or alarm) - Product Code MHX
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Product | Philips IntellVue Info Center iX 866023; PIIC iX Upgrade 866024; IntellVue Server iX Upgrade 866026; PIIC Classic Upgrade 866117 Patient Physiological Monitor. |
Code Information |
All iX versions with A.01 software |
Recalling Firm/ Manufacturer |
Philips Healthcare Inc. 3000 Minuteman Road Andover MA 01810
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For Additional Information Contact | 978-687-1501 |
Manufacturer Reason for Recall | If a customer creates customized trend scales in the trend review tile and the iX or primary server reboots for any reason, the iX(s) will enter a reboot loop. If one iX reboots, the issue will impact only those patients monitored on that device. If the primary server reboots, all patients across all iX devices will be impacted. |
FDA Determined Cause 2 | Software design |
Action | On 3/5/13, Philips sent each known affected customer an Urgent Medical Device Correction notification/Field Safety Notice to inform them that Philips has received a customer report that the PIC iX (release A.01.XX) central stations that are connected to a database server (DBS) may not be able to complete a restart/reboot resulting in the loss of central monitoring. In order to prevent this from occurring, customers were advised to not modify/customize the default trend scales for reviewing stored patient data in the retrospective review applications.
Recall letter also states that a Philips Healthcare representative will contact customers with affected devices to arrange for the installation of updated PIIX iX software resolving this issue on affected units. Philips will conduct these updates for all affected devices at no charge. |
Quantity in Commerce | 899 |
Distribution | Worldwide Distribution: US (nationwide) and country of: Canada. |
Total Product Life Cycle | TPLC Device Report |
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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.
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510(K) Database | 510(K)s with Product Code = MHX
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