Z-0911-2017Class II

Prestige II

Name: Z-0911-2017 Prestige II
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 Prestige II 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-0911-2017
Classification: Class II
Status: Terminated
Initiated: 2016-11-21
Posted: 2016-12-23
Terminated: 2017-09-26
Recalling firm: GE Healthcare
Product: Prestige II
Product code: JAA System, X-Ray, Fluoroscopic, Image-Intensified
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 00000128555MO0 850526JR3 00000089643MO1 305227PRESTIGE1 00000094666MO5 305227PRESTIGE2 00000063792YY6 708216REM1 00000100104MO9 219416PRE 00000118238MO5 317338SVP 00000119906MO6 228314RF 00000113951MO8 662513RF2 Not Available 662513RF1 00000063697YY7 919472CGRFB 00000113961MO7 718262REM1 00000052137YY7 843692PRES 00000010115MO5 803778RF1 00000128514MO7 423493PRF4 Not Available 901226R9 Not Available 204623RF1 00000128614MO5 519685REM 00000063717YY3 905895RM3 00000113955MO9 905358REM 00000128544MO4 519631REM 00000128595MO6 326582XF1 00000063685YY2 082408040013 00000063685YY2 082408040013 00000063761YY1 082408100085 00000063716YY5 EG1024RX01 Not Available HDAR01XR02 00000128613MO7 IS1001RF01 00000063688YY6 A5181620 Not Available A5487204 00000063749YY6 B5130612 Not Available 0850080467 Not Available LY1006XR03 00000119921MO5 0853080154 00000063700YY9 0853080151 00000063700YY9 0853080151 00000119921MO5 0853080154 Not Available 38828380XRNOR 00000063753YY8 38811857XRAND 00000063767YY8 0859080008

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0911-2017
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 JAA

K943805Class IIPrestige Remote R & F System Models H, Vh & VhdGeneral Electric Co. / cleared 1994-09-23

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)