Getinge Usa Sales Inc: Flow Anesthesia Systems Recalled for Cybersecurity Vulnerabilities

Agency Publication Date: February 6, 2024

Summary

Getinge USA Sales Inc. has recalled 248 units of its Flow Anesthesia Systems, including models Flow-i C20, C30, C40, Flow-c, and Flow-e, due to a potential cybersecurity vulnerability. This software flaw could allow unauthorized remote access, potentially leading to a denial-of-service attack or remote control of the device during medical procedures. These systems are used in hospitals across 20 states and internationally to provide anesthesia and ventilation to patients. Consumers and healthcare facilities should contact the manufacturer immediately for instructions on securing their devices.

Risk

An unauthorized user could remotely log into the anesthesia system to tamper with settings or disable the device. This could lead to a sudden loss of anesthesia or ventilation during surgery, posing a life-threatening hazard to patients.

What You Should Do

Check your anesthesia system's model and serial number to see if it is affected. The recall includes Flow-i C20 (Model 6677200), Flow-i C30 (Model 6677300), Flow-i C40 (Model 6677400), Flow-c (Model 6887700), and Flow-e (Model 6887900).
Locate the serial number on the device and compare it against the hundreds of affected numbers, such as Flow-i C20 units 1202 through 8027, Flow-i C30 units 1058, 1060, 1167, and 1201, or Flow-e units ranging from 50012 to 50277.
Verify if your device has the UDI-DI 07325710001349, 07325710001363, 07325710001318, 07325710009765, or 07325710010457 printed on the product labeling.
Contact Getinge USA Sales Inc. at their Wayne, New Jersey headquarters or through your authorized service representative to receive guidance on software updates or security protocols to mitigate this remote login risk.
Consult with your facility's IT and cybersecurity departments to ensure the Flow Anesthesia System is on a secure, restricted network to prevent unauthorized remote access.
For further information or questions regarding this recall, contact the FDA at 1-888-INFO-FDA (1-888-463-6332) or visit the FDA medical device recall website.

Your Remedy Options

Other Action

Contact the manufacturer for mitigation and security protocols.

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Flow-i C20 Anesthesia System

Model / REF:

6677200

UPC Codes:

07325710001349

Lot Numbers:

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

Product: Flow-i C30 Anesthesia System

Model / REF:

6677300

UPC Codes:

07325710001363

Lot Numbers:

Serial Numbers (US): 1058, 1060, 1167, 1201

Product: Flow-i C40 Anesthesia System

Model / REF:

6677400

UPC Codes:

07325710001318

Lot Numbers:

Serial Numbers (US): 5204, 5205, 5206, 5207, 5208, 5209, 5210, 5211, 7185, 7982, 7983, 8426, 8427, 8428, 8445, 8446

Product: Flow-c Anesthesia System

Model / REF:

6887700

UPC Codes:

07325710009765

Lot Numbers:

Serial Numbers (US): 5024, 5025, 5026, 5027, 5028, 5043, 5044, 5045, 5046, 5047, 5048, 5049, 5050, 5078

Product: Flow-e Anesthesia System

Model / REF:

6887900

UPC Codes:

07325710010457

Lot Numbers:

Serial Numbers (US): 50012, 50030, 50031, 50033, 50034, 50035, 50036, 50037, 50038, 50039, 50040, 50041, 50042, 50043, 50046, 50047, 50048, 50051, 50052, 50053, 50054, 50055, 50056, 50057, 50058, 50059, 50060, 50069, 50070, 50071, 50072, 50073, 50074, 50084, 50085, 50086, 50087, 50088, 50089, 50090, 50091, 50092, 50093, 50094, 50096, 50097, 50108, 50109, 50110, 50111, 50132, 50154, 50155, 50193, 50194, 50195, 50196, 50197, 50199, 50211, 50212, 50213, 50214, 50215, 50216, 50217, 50218, 50219, 50220, 50221, 50223, 50224, 50225, 50244, 50245, 50246, 50247, 50248, 50249, 50250, 50251, 50252, 50253, 50254, 50276, 50277

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 93736

Status: Active

Manufacturer: Getinge Usa Sales Inc

Sold By: Direct Sales; Medical Supply Distributors

Manufactured In: United States

Units Affected: 5 products (128 (US); 4 (US); 16 (US); 14 (US); 86 (US))

Distributed To: Alabama, Arkansas, Arizona, California, Colorado, District of Columbia, Florida, Georgia, Indiana, Massachusetts, Michigan, Missouri, New York, Ohio, Oregon, Pennsylvania, Texas, Virginia, Washington, West Virginia

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

Check your anesthesia system's model and serial number to see if it is affected. The recall includes Flow-i C20 (Model 6677200), Flow-i C30 (Model 6677300), Flow-i C40 (Model 6677400), Flow-c (Model 6887700), and Flow-e (Model 6887900).

Locate the serial number on the device and compare it against the hundreds of affected numbers, such as Flow-i C20 units 1202 through 8027, Flow-i C30 units 1058, 1060, 1167, and 1201, or Flow-e units ranging from 50012 to 50277.

Verify if your device has the UDI-DI 07325710001349, 07325710001363, 07325710001318, 07325710009765, or 07325710010457 printed on the product labeling.

Contact Getinge USA Sales Inc. at their Wayne, New Jersey headquarters or through your authorized service representative to receive guidance on software updates or security protocols to mitigate this remote login risk.

Consult with your facility's IT and cybersecurity departments to ensure the Flow Anesthesia System is on a secure, restricted network to prevent unauthorized remote access.

For further information or questions regarding this recall, contact the FDA at 1-888-INFO-FDA (1-888-463-6332) or visit the FDA medical device recall website.

Affected Products

Product: Flow-i C20 Anesthesia System

Model / REF:

6677200

UPC Codes:

07325710001349

Lot Numbers:

Product: Flow-i C30 Anesthesia System

Model / REF:

6677300

UPC Codes:

07325710001363

Lot Numbers:

Serial Numbers (US): 1058, 1060, 1167, 1201

Product: Flow-i C40 Anesthesia System

Model / REF:

6677400

UPC Codes:

07325710001318

Lot Numbers:

Serial Numbers (US): 5204, 5205, 5206, 5207, 5208, 5209, 5210, 5211, 7185, 7982, 7983, 8426, 8427, 8428, 8445, 8446

Product: Flow-c Anesthesia System

Model / REF:

6887700

UPC Codes:

07325710009765

Lot Numbers:

Serial Numbers (US): 5024, 5025, 5026, 5027, 5028, 5043, 5044, 5045, 5046, 5047, 5048, 5049, 5050, 5078

Product: Flow-e Anesthesia System

Model / REF:

6887900

UPC Codes:

07325710010457

Lot Numbers:

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 93736

Status: Active

Manufacturer: Getinge Usa Sales Inc

Sold By: Direct Sales; Medical Supply Distributors

Manufactured In: United States

Units Affected: 5 products (128 (US); 4 (US); 16 (US); 14 (US); 86 (US))