Z-0905-2017Class II

Advantx Lca

Name: Z-0905-2017 Advantx Lca
Creator: GE Healthcare, LLC
Published: 2016-11-21
License: https://open.fda.gov/license/

GE Healthcare / initiated 2016-11-21 / Terminated / root cause: manufacturing process

FDA source

GE Healthcare, LLC began a recall of ADVANTX LCA on 2016-11-21. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0905-2017
Classification: Class II
Status: Terminated
Initiated: 2016-11-21
Posted: 2016-12-23
Terminated: 2017-09-26
Recalling firm: GE Healthcare
Product: Advantx Lca
Product code: IZI System, X-Ray, Angiographic
Reason for recall: 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 tag: manufacturing process
FDA 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 in commerce: 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
Product codes and lots: Mfg. Lot or Serial # System ID 00000048085YY5 706354SLCA 00000063506YY0 919443NGLCA Not Available 518761GLCA 00000052178YY1 914632LCA 00000052138YY5 740446LCA 00000063620YY9 843797LCA Not Available 414D1126 00000034252YY7 YX0950

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0905-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0904-2017	Class II	Terminated	Voluntary: Firm initiated	2017-01-04	2016-12-23
Z-0905-2017	Class II	Terminated	Voluntary: Firm initiated	2017-01-04	2016-12-23
Z-0906-2017	Class II	Terminated	Voluntary: Firm initiated	2017-01-04	2016-12-23
Z-0907-2017	Class II	Terminated	Voluntary: Firm initiated	2017-01-04	2016-12-23
Z-0908-2017	Class II	Terminated	Voluntary: Firm initiated	2017-01-04	2016-12-23
Z-0909-2017	Class II	Terminated	Voluntary: Firm initiated	2017-01-04	2016-12-23
Z-0910-2017	Class II	Terminated	Voluntary: Firm initiated	2017-01-04	2016-12-23
Z-0911-2017	Class II	Terminated	Voluntary: Firm initiated	2017-01-04	2016-12-23
Z-0912-2017	Class II	Terminated	Voluntary: Firm initiated	2017-01-04	2016-12-23
Z-0913-2017	Class II	Terminated	Voluntary: Firm initiated	2017-01-04	2016-12-23
Z-0914-2017	Class II	Terminated	Voluntary: Firm initiated	2017-01-04	2016-12-23
Z-0915-2017	Class II	Terminated	Voluntary: Firm initiated	2017-01-04	2016-12-23
Z-0916-2017	Class II	Terminated	Voluntary: Firm initiated	2017-01-04	2016-12-23

Product code IZI

K945375Class IIAdvantx LcaGE Medical Systems / cleared 1995-01-30

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)