GE Healthcare Innova IGS 3 (GTIN 00840682147378), Innova IGS 5 (GTIN 00840682124621), Innova IGS 6 (GTIN 00840682124614)
FDA device recall Z-1864-2021 · posted 2021-06-15 · Terminated
Recall details
- Recalling firm
- GE Healthcare, LLC
- Reason for recall
- The IGS system can experience a single vertical line defect where the vertical line divides and horizontally shifts live monitor images into two unequal image parts within the monitor display screen.
- Action taken
- The recalling firm issued letters dated 4/19/2021 via traceable mail on 4/20/21 and issued an additional letter dated 4/28/2021 to correct an omission of serial numbers (only sent to the affected consignees).
- Root cause
- Component change control
- Status
- Terminated
- Product code
- OWB
- Quantity affected
- 139 devices
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of CA, CO, FL, GA, KY, LA, MA, MO, MS, NC, NJ, NV, NY, PA, SC, TN, TX, VA, WA, and WI. Government distribution was made and potentiall
- Date initiated
- 2021-04-19
- Date posted
- 2021-06-15
- Date terminated
- 2023-08-31
- Location
- Waukesha, WI
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Innova IGS 5, Innova IGS 6, Discovery IGS 7, Discovery IGS 7 OR (K181403) | GE Healthcare | 2018-11-02 |