GE Healthcare Centricity Universal Viewer Zero Footprint Client, Model Numbers: a) 2110344-008; b) 2110344-009; c) 21103
FDA device recall Z-3160-2024 · posted 2024-09-17 · Open, Classified
Recall details
- Recalling firm
- GE Healthcare
- Reason for recall
- Footprint Client (ZFP) versions v6.0 SP9.x and SP10.x where the latest addended report is not shown by default to the user. The issue occurs when the addendum is created on the same day as the original report but at a different time, and only when launched on the following browsers. " Internet Explorer 10 (IE10) " Internet Explorer 11 (IE11) " Firefox.
- Action taken
- GE Healthcare issued an URGENT MEDICAL DEVICE CORRECITON notice to its consignees on 07/23/2023 via letter. The notice explained the issue, potential risk to the patient, and provided the following actions be taken: "You can continue to use your device. Please ensure all potential users in your facility are made aware of this safety notification and the recommended actions below. Follow one of the below recommendations to ensure the latest addendum is being reviewed: 1. Use Microsoft Edge or Google Chrome browsers when launching ZFP Viewer. OR 2. If you cannot use the browsers listed in #1, to find the addendum / latest report, review all the reports available for the study in the Series Selector. Navigation to the series selection can be found in the User Manual under Section 2.3.3 of The Series Selector, with subheading as Open a report/document using series selector"." GE HealthCare will correct all affected products at no cost to you. A GE HealthCare representative will contact you to arrange for the correction. For questions or concerns regarding this notification, please contact GE HealthCare Service at 1-800-437-1171 or your local Service Representative.
- Root cause
- Software Design Change
- Status
- Open, Classified
- Product code
- LLZ
- Quantity affected
- 803 units
- Distribution
- Worldwide distribution.
- Date initiated
- 2024-07-23
- Date posted
- 2024-09-17
- Location
- Chicago, IL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CENTRICITY UNIVERSAL VIEWER ZERO FOOTPRINT CLIENT (K131977) | GE Healthcare | 2013-09-17 |