FDA Medical Device Recalls (openFDA)
GE Healthcare, LLC: ADVANTX LCLP+
- Recall number
- Z-0906-2017
- Recalling firm
- GE Healthcare, LLC
- Product
- ADVANTX LCLP+
- 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 00000047915YY4 415540ADVLCLP 00000063721YY5 909865LCLP Not Available 916734XR 00000063736YY3 MCTHKGMN 00000023830YY3 912633MCL1 00000023761YY0 912633MCL1 00000128484M03 312CCHGECATH 00000128484MO3 312CCHGECATH Not Available 507255CC101 Not Available LIJ015064 00000026160YY2 210428VCATH2 00000063805YY6 BPEP Not Available 414C4862 00000022150YY7 YX0738
- 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