🔍 RecallPedia

Innova IGS 630, 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.

Class I - Dangerous
🏥 Medical Devices Recalled: March 15, 2019 GE Healthcare Diagnostic Equipment Nationwide

What Should You Do?

  1. Check if you have this product:
    Model Number 5730860; System ID (Serial Number, UDI Number): 352333VASC3 (B3-17-006, 01008406821086381117020021B3-17-006); 727869SPECIALS (B3-18-005, 01008406821086381118020021B3-18-005); 407518BIPLANE (B3-17-005, 01008406821086381117010021B3-17-005); 305227KBP630 (B3-16-017, 01008406821086381116080021B3-16-017); 401BIPLANE1 (B3-18-001, 01008406821086381118010021B3-18-001); 941629IGS630 (B3-18-002, 01008406821086381118010021B3-18-002); 505841CATH3 (B3-17-032, 01008406821086381117120021B3-17-032); 7022553131 (B3-17-011, 01008406821086381117030021B3-17-011); 7028803131 (B3-17-023, 01008406821086381117080021B3-17-023); 615769SP3 (B3-17-013, 01008406821086381117040021B3-17-013); 214618INIGS (B3-16-029, 01008406821086381116120021B3-16-029); 281890BP (B3-17-024, 01008406821086381117090021B3-17-024); 956632IGS630 (B3-17-029, 01008406821086381117120021B3-17-029); 804320IGS630 (B3-16-016, 01008406821086381116070021B3-16-016); DZ1009VA03 (B3-17-015, 01008406821086381117070021B3-17-015); 220826RX10 (B3-17-003, 01008406821086381117010021B3-17-003); 082416040099 (B3-19-001, 01008406821086381119020021B3-19-001); 082416160088 (B3-18-023, 01008406821086381118110021B3-18-023); 082416100170 (B3-19-003, 01008406821086381119020021B3-19-003); XV8624CO (B3-18-012, 01008406821086381118050021B3-18-012); N4192956 (B3-17-009, 01008406821086381117030021B3-17-009); A5820150 (B3-16-023, 01008406821086381116100021B3-16-023); YV1920 (B3-16-020, 01008406821086381116100021B3-16-020); YV1922 (B3-17-002, 01008406821086381117010021B3-17-002); YV1921 (B3-16-027, 01008406821086381116120021B3-16-027); YV4500 (B3-16-032, 01008406821086381117010021B3-16-032); YV4501 (B3-17-027, 01008406821086381117110021B3-17-027); YV2503 (B3-16-019, 01008406821086381116090021B3-16-019); YV4503 (B3-18-003, 01008406821086381118020021B3-18-003); YV4502 (B3-17-030, 01008406821086381117120021B3-17-030); 0850060758 (B3-17-014, 01008406821086381117070021B3-17-014); 0850060755 (B3-17-001, 01008406821086381117010021B3-17-001); 0850060759 (B3-18-013, 01008406821086381118060021B3-18-013); KW1008VA01 (B3-17-019, 01008406821086381117070021B3-17-019); KW1005VA02 (B3-16-025, 01008406821086381116110021B3-16-025); KW1005VA01 (B3-16-026, 01008406821086381116110021B3-16-026); LY1067VA01 (B3-17-010, 01008406821086381117030021B3-17-010); PK1003VA01 (B3-17-018, 01008406821086381117060021B3-17-018); RU2011VA02 (B3-17-004, 01008406821086381117010021B3-17-004); RU9774VA01 (B3-16-021, 01008406821086381116100021B3-16-021); SA2513VA01 (B3-16-024, 01008406821086381116100021B3-16-024); ZA2940VA01 (B3-17-025, 01008406821086381117100021B3-17-025); SD1084VA01 (B3-18-010, 01008406821086381118050021B3-18-010); 06189VAS06 (B3-17-028, 01008406821086381117110021B3-17-028); 55001VAS02 (B3-16-031, 01008406821086381116120021B3-16-031); 5973XR0085 (B3-17-007, 01008406821086381117020021B3-17-007); 5973XR0075 (B3-16-030, 01008406821086381116120021B3-16-030); 5973XR0076 (B3-17-008, 01008406821086381117030021B3-17-008); 5973XR0094 (B3-17-012, 01008406821086381117040021B3-17-012)
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
GE Healthcare, LLC
Reason for Recall:
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.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

Innova IGS 630, 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.

Product Codes/Lot Numbers:

Model Number 5730860; System ID (Serial Number, UDI Number): 352333VASC3 (B3-17-006, 01008406821086381117020021B3-17-006); 727869SPECIALS (B3-18-005, 01008406821086381118020021B3-18-005); 407518BIPLANE (B3-17-005, 01008406821086381117010021B3-17-005); 305227KBP630 (B3-16-017, 01008406821086381116080021B3-16-017); 401BIPLANE1 (B3-18-001, 01008406821086381118010021B3-18-001); 941629IGS630 (B3-18-002, 01008406821086381118010021B3-18-002); 505841CATH3 (B3-17-032, 01008406821086381117120021B3-17-032); 7022553131 (B3-17-011, 01008406821086381117030021B3-17-011); 7028803131 (B3-17-023, 01008406821086381117080021B3-17-023); 615769SP3 (B3-17-013, 01008406821086381117040021B3-17-013); 214618INIGS (B3-16-029, 01008406821086381116120021B3-16-029); 281890BP (B3-17-024, 01008406821086381117090021B3-17-024); 956632IGS630 (B3-17-029, 01008406821086381117120021B3-17-029); 804320IGS630 (B3-16-016, 01008406821086381116070021B3-16-016); DZ1009VA03 (B3-17-015, 01008406821086381117070021B3-17-015); 220826RX10 (B3-17-003, 01008406821086381117010021B3-17-003); 082416040099 (B3-19-001, 01008406821086381119020021B3-19-001); 082416160088 (B3-18-023, 01008406821086381118110021B3-18-023); 082416100170 (B3-19-003, 01008406821086381119020021B3-19-003); XV8624CO (B3-18-012, 01008406821086381118050021B3-18-012); N4192956 (B3-17-009, 01008406821086381117030021B3-17-009); A5820150 (B3-16-023, 01008406821086381116100021B3-16-023); YV1920 (B3-16-020, 01008406821086381116100021B3-16-020); YV1922 (B3-17-002, 01008406821086381117010021B3-17-002); YV1921 (B3-16-027, 01008406821086381116120021B3-16-027); YV4500 (B3-16-032, 01008406821086381117010021B3-16-032); YV4501 (B3-17-027, 01008406821086381117110021B3-17-027); YV2503 (B3-16-019, 01008406821086381116090021B3-16-019); YV4503 (B3-18-003, 01008406821086381118020021B3-18-003); YV4502 (B3-17-030, 01008406821086381117120021B3-17-030); 0850060758 (B3-17-014, 01008406821086381117070021B3-17-014); 0850060755 (B3-17-001, 01008406821086381117010021B3-17-001); 0850060759 (B3-18-013, 01008406821086381118060021B3-18-013); KW1008VA01 (B3-17-019, 01008406821086381117070021B3-17-019); KW1005VA02 (B3-16-025, 01008406821086381116110021B3-16-025); KW1005VA01 (B3-16-026, 01008406821086381116110021B3-16-026); LY1067VA01 (B3-17-010, 01008406821086381117030021B3-17-010); PK1003VA01 (B3-17-018, 01008406821086381117060021B3-17-018); RU2011VA02 (B3-17-004, 01008406821086381117010021B3-17-004); RU9774VA01 (B3-16-021, 01008406821086381116100021B3-16-021); SA2513VA01 (B3-16-024, 01008406821086381116100021B3-16-024); ZA2940VA01 (B3-17-025, 01008406821086381117100021B3-17-025); SD1084VA01 (B3-18-010, 01008406821086381118050021B3-18-010); 06189VAS06 (B3-17-028, 01008406821086381117110021B3-17-028); 55001VAS02 (B3-16-031, 01008406821086381116120021B3-16-031); 5973XR0085 (B3-17-007, 01008406821086381117020021B3-17-007); 5973XR0075 (B3-16-030, 01008406821086381116120021B3-16-030); 5973XR0076 (B3-17-008, 01008406821086381117030021B3-17-008); 5973XR0094 (B3-17-012, 01008406821086381117040021B3-17-012)

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1200-2019

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