GE Healthcare, LLC: Innova IGS 6, Interventional Fluoroscopic X-Ray System used in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and non-vascular, diagnostic and interventional procedures.

Recall number

Z-1201-2019

Recalling firm

GE Healthcare, LLC

Product

Innova IGS 6, Interventional Fluoroscopic X-Ray System used in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and non-vascular, diagnostic and interventional procedures.

Status

Open, Classified

Initiated

2019-03-15

Posted

not on file

Terminated

not on file

Reason

There is a potential for loss of the x-ray imaging function when the user changes field of view (FOV) from 30cm to 20cm or from 20cm to 30cm while releasing the fluoroscopy footswitch pedal simultaneously.

Root cause

Device Design

Action

GE Healthcare notified customers on about 03/15/2019 via "URGENT MEDICAL DEVICE CORRECTION" letter. Customer were informed that they can continue to use their Innova IGS 6 or Innova IGS 630 Systems but must follow the following safety instructions: 1. Do not change the size of the field of view from 30cm to 20cm or 20cm to 30cm while releasing the fluoroscopy footswitch pedal. 2. Only perform these 2 actions sequentially. 3. If the system becomes locked up, perform a reset to recover functionalities. Customers were also informed that GE Healthcare will correct all affected products at no cost and a GE Healthcare representative will contact each customer to perform the correction. After the GE representative has updated the system, please destroy previous Innova IGS 6 SW package installation media related to this system (versions prior to IGS6_2.2.1 or IGS6_3.1.1). Questions or concerns can be directed to GE Healthcare Service at 1-800-437-1171 or your local Service Representative.

Quantity

22 devices

Distribution

Nationwide distribution to AR, CA, CA, FL, MI, NM, NV, SC, TN, TX, VA, WA, WI. International distribution to Algeria, Belgium, China, Colombia, France, Hungary, Italy, Japan, Korea (Republic Of), Kuwait, Libya, Pakistan, Poland, Russia, Saudi Arabia, South Africa, Sudan, Turkey, Vietnam.

Lot, serial or model codes

Model Number 5771387;   System ID (Serial Number, UDI Number): 501257IGS630 (B3-18-014, 01008406821246141118070021B3-18-014); 951486RU630 (B3-18-009, 01008406821246141118040021B3-18-009); 714993IGS630 (B3-18-004, 01008406821246141118020021B3-18-004); 906225EP1 (B3-18-015, 01008406821246141118070021B3-18-015); 906225CATH4 (B3-18-016, 01008406821246141118080021B3-18-016); 843797IGS30 (B3-18-030, 01008406821246141119010021B3-18-030); 4603984XV41 (B3-18-019, 01008406821246141118090021B3-18-019); MCARIGS630 (B3-18-008, 01008406821246141118040021B3-18-008); 509473RM1B (B3-18-028, 01008406821246141119010021B3-18-028); 414649IGS8 (B3-18-020, 01008406821246141118090021B3-18-020); HU1099VA07 (B3-18-024, 01008406821246141118110021B3-18-024); A670060221 (B3-19-002, 01008406821246141119020021B3-19-002); A5163326 (B3-18-007, 01008406821246141118030021B3-18-007); YV4504 (B3-18-018, 01008406821246141118090021B3-18-018); YV4505 (B3-18-027, 01008406821246141118120021B3-18-027); YV4507 (B3-18-022, 01008406821246141118110021B3-18-022); 0850060762 (B3-18-025, 01008406821246141118110021B3-18-025); 0850060763 (B3-18-026, 01008406821246141118120021B3-18-026); KW1155VA02 (B3-18-017, 01008406821246141118080021B3-18-017); PL1689VA01 (B3-18-021, 01008406821246141118100021B3-18-021); PL0302VA02 (B3-18-011, 01008406821246141118060021B3-18-011); 06189VAS11 (B3-18-029, 01008406821246141119010021B3-18-029)

510(k) numbers

["K181403"]

PMA numbers

not on file

Product code

IZI

Firm FEI

2126677

Firm city

Waukesha

Firm state

WI

Firm country

not on file

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

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