FDA Medical Device Recalls (openFDA)
GE Healthcare, LLC: ADVANTX LCN+
- Recall number
- Z-0907-2017
- Recalling firm
- GE Healthcare, LLC
- Product
- ADVANTX LCN+
- Status
- Terminated
- Initiated
- 2016-11-21
- Posted
- not on file
- Terminated
- 2017-09-26
- Reason
- GE Healthcare is conducting a recall due to the potential fall of aged CRT monitors - Prestige 2, Prestilix, Prestige VH, Prestige SI, RFX/SFX, Legacy, Precision 500D, ADVANTX and Innova 2000 systems.
- Root cause
- Nonconforming Material/Component
- Action
- Consignees were sent on 11/21/2016 a GE Healthcare "Urgent Medical Device Correction" letter GEHC Ref# FMI 10913 dated November 21, 2016. The letter was addressed to Director of Radiology, Risk Manager/Hospital Administrator, and Director of Biomedical Engineering. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information. 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.
- Quantity
- Total for all products 1,598 (USA 824, OUS 774)
- Distribution
- US: AL, AR, AZ, CA, CO, CT, DC, FL, GA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT,NC, NE NH, NJ, NM, NY, NV, OH, OK, PA, RI, SC, SD, TN, TX,, VA, WA, WO, WY, WV. OUS: Algeria Armenia Australia Austria Brazil Canada Chile China Denmark Egypt France Germany Guatemala Honduras Hong Kong Hungary Iceland India Ireland Italy Japan Korea Libya Mexico Netherlands Netherlands Peru Poland Portugal Russia Saudi Arabia Serbia Sierra Leone Slovakia Spain Taiwan Thailand Turkey United Arab Emirates United Kingdom Venezuela Vietnam
- Lot, serial or model codes
- Mfg. Lot or Serial # System ID 00000089619MO1 205592MLC 00000089632MO4 205592MLC 00000052196YY3 601459LC 00000023729YY7 910343NHC1 00000031441YY9 603668CLC3 00000034211YY3 603668CLC3 00000034271YY7 973429CATH Not Available 215576LC2 Not Available 610250SC Not Available 0910062022 Not Available 0910062022 00000023777YY6 1025 00000026231YY1 3919-1 00000023841YY0 93162 00000023841YY0 93162 Not Available GOLD000540
- 510(k) numbers
- ["K974367"]
- PMA numbers
- not on file
- Product code
- IZI
- Firm FEI
- 2126677
- Firm city
- Waukesha
- Firm state
- WI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
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