Centricity Universal Viewer 6.0 Is a device that displays medical images and data from various imaging sources, and from
FDA device recall Z-1910-2019 · posted 2019-07-01 · Terminated
Recall details
- Recalling firm
- GE Healthcare, LLC
- Reason for recall
- There is the possibility of viewing studies directly from the Enterprise Archive or VNA with incorrect patient images because the updated series or study is not present in the archive.
- Action taken
- On May 20, 2019, the firm, GE Healthcare, sent an " URGENT MEDICAL DEVICE CORRECTION" letter date 5/20/2019 to their consignees. The letter described the product, problem and actions to be taken. The customers were instructed to do the following: discontinue use of the UV study management functionality for study split/study info updates until a correction is available and to wait for a GE representative to contact them to arrange for the correction. If you have any questions or concerns regarding this notification, please contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- LLZ
- Quantity affected
- 145 (87 US 103 OUS)
- Distribution
- Worldwide Distribution: US (nationwide) to states of: FL, GA, IL, IN, LA, MA, MO, NJ, NY, OR, PA, SC, SD, TX, and WA; and countries of : Brazil, Canada, Chile, France, French Polynesia, Germany, India
- Date initiated
- 2019-05-16
- Date posted
- 2019-07-01
- Date terminated
- 2023-04-14
- Location
- Waukesha, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Centricity Universal Viewer (K182419) | GE Healthcare | 2018-12-14 |
| Centricity Universal Viewer (K150420) | GE Healthcare | 2015-05-26 |