Z-0916-2017Class II

Sfx

Name: Z-0916-2017 Sfx
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 SFX 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-0916-2017
Classification: Class II
Status: Terminated
Initiated: 2016-11-21
Posted: 2016-12-23
Terminated: 2017-09-26
Recalling firm: GE Healthcare
Product: Sfx
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 00000119847MO2 205345RF2 Not Available 501239AMR3 00000063563YY1 602588OP1 Not Available 805326KM3 00000031477YY3 619725RM2 00000031386YY6 619725RM6 Not Available 707263LXR2 Not Available 209578AVTX 00000034272YY5 805497RM7 00000031317YY1 916555RF1 00000039665YY5 415750S9 00000026124YY8 415565DFL2 00000063453YY5 714985R3 Not Available 813932SPEC 00000023723YY0 229312DRS Not Available 404589GSF 00000026193YY3 404791D4A 00000063484YY0 319652ADVRF Not Available 618549CMRF1 00000023674YY5 317662RM4 Not Available 317662RM3 Not Available 812232ARM2 00000023719YY8 502746RF Not Available 318948DRS Not Available 301891RM1 Not Available 410337RF 00000023681YY0 313493ADV 00000023705YY7 517334ADV 00000022193YY7 612243RF 00000031310YY6 816276BRF1 Not Available 704342NR5 Not Available 704765RF1 00000022177YY0 201858RM3 00000022171YY3 505887GRF1 00000022159YY8 505392RF2 Not Available 516579R2 00000052108YY8 718739RF 00000023699YY2 212844RM3 00000031337YY9 405323CRF 00000039657YY2 215831SP Not Available 803522B2 00000052115YY3 803899RF1 00000023744YY6 423926RF Not Available 409883BRF 00000023676YY0 817735FP2 00000026181YY8 703783ARF4 Not Available 703459RF1 00000026111YY5 414529RF1 Not Available 414D1183 00000023843YY6 304348MX8 00000022190YY3 304647GX1 00000022132YY5 00658FLU01

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0916-2017
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

K801320Class IISfx-90 Table/spotfilmer W/fluoricon L200General Electric Co. / cleared 1980-07-21

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)