Flow-i C20 Anesthesia System, model 6677200
Class I - DangerousWhat Should You Do?
- Check if you have this product: UDI-DI: 07325710001349, Serial Numbers (US): 1202, 1224, 1281, 1282, 1545, 1546, 1651, 1657, 1786, 1787, 1860, 1861, 2023, 2024, 2095, 2186, 2557, 2558, 2559, 2560, 2613, 2714, 2716, 2719, 2720, 2721, 2722, 2723, 2724, 2729, 2730, 2731, 2732, 2733, 2735, 2736, 2737, 2738, 2739, 2740, 2741, 2742, 2743, 2744, 2745, 2746, 2747, 2853, 2854, 2855, 2856, 2858, 2859, 2860, 2861, 2862, 2863, 2864, 2865, 2866, 2867, 2868, 2869, 4261, 4548, 4549, 4550, 5198, 5199, 5200, 5201, 5202, 5203, 5428, 5429, 5540, 5541, 5542, 5589, 5590, 5812, 5813, 5814, 5895, 6132, 6133, 6525, 6562, 6736, 6737, 6819, 6820, 6821, 6822, 6823, 6824, 6940, 7818, 7984, 7985, 7986, 7987, 7989, 7990, 7991, 7992, 7993, 7994, 8008, 8009, 8010, 8011, 8012, 8013, 8014, 8015, 8016, 8017, 8018, 8019, 8020, 8021, 8022, 8023, 8024, 8025, 8026, 8027.
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- 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:
- Getinge Usa Sales Inc
- Reason for Recall:
- Potential cybersecurity vulnerability that could lead to a Denial of Service (DoS) attack, tampering, or remote code execution via remote login to the Flow Anesthesia System, any of which could lead to a hazardous situation.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Flow-i C20 Anesthesia System, model 6677200
Product Codes/Lot Numbers:
UDI-DI: 07325710001349, Serial Numbers (US): 1202, 1224, 1281, 1282, 1545, 1546, 1651, 1657, 1786, 1787, 1860, 1861, 2023, 2024, 2095, 2186, 2557, 2558, 2559, 2560, 2613, 2714, 2716, 2719, 2720, 2721, 2722, 2723, 2724, 2729, 2730, 2731, 2732, 2733, 2735, 2736, 2737, 2738, 2739, 2740, 2741, 2742, 2743, 2744, 2745, 2746, 2747, 2853, 2854, 2855, 2856, 2858, 2859, 2860, 2861, 2862, 2863, 2864, 2865, 2866, 2867, 2868, 2869, 4261, 4548, 4549, 4550, 5198, 5199, 5200, 5201, 5202, 5203, 5428, 5429, 5540, 5541, 5542, 5589, 5590, 5812, 5813, 5814, 5895, 6132, 6133, 6525, 6562, 6736, 6737, 6819, 6820, 6821, 6822, 6823, 6824, 6940, 7818, 7984, 7985, 7986, 7987, 7989, 7990, 7991, 7992, 7993, 7994, 8008, 8009, 8010, 8011, 8012, 8013, 8014, 8015, 8016, 8017, 8018, 8019, 8020, 8021, 8022, 8023, 8024, 8025, 8026, 8027.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0987-2024
Related Recalls
Vaporizer Sevoflurane, Quik-Fil. Model Number: 6682285. Device is a component of Flow-i C20, Flow-i C30, Flow-i C40, Flow-c, Flow-e. For use during anesthesia.
Getinge Usa Sales
Sevoflurane used with the vaporizer may degrade to hydrogen fluoride, which could present a risk to patients or health care providers through inhalation and/or skin exposure. Potential harms include irritation of respiratory tract, which in worst case may lead to lung edema and/or severe hypocalcemia, blistering, superficial ulceration, and/or hypomagnesemia.
Error code "50037" occurs on the IR-Hand Control when a MEERA-table is controlled, and the table stops the movement. This error may occur sporadically when the MEERA-table is controlled via an IR-Hand Control and may result in procedural delay
Error code "50037" occurs on the IR-Hand Control when a MEERA-table is controlled, and the table stops the movement. This error may occur sporadically when the MEERA-table is controlled via an IR-Hand Control and may result in procedural delay