Devices

Device Recall Terumo APS 1

Model / Serial
Serial numbers 00010, 00011, 00012, 00013, 00014, 00015, 00016, 00017, 00019, 00020, 00024 through 00038, 00040, 00042 through 00050, 00052 through 00063, 00065 through 00082, 00084 through 00096, 00098 through 00103, 00105 through 00123, 00125 through 00152, 00154 through 00160, 00162 through 00174, 00176 through 00197, 00199 through 00208, 00211, 00213 through 00224 and 00226.
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide, including USA, Belgium, Canada, China, Dominican Republic, Egypt, Germany, India, Indonesia, Japan, Malaysia, Mexico, Pakistan, Singapore, South Africa, South Korea, Thailand and United Arab Emirates.
Product Description
Terumo Advanced Perfusion System 1 Electronic Oxygen Blender/analyzer; Catalog number 801188.
Manufacturer
Terumo Cardiovascular Systems Corp
1 Event
- Recall of Device Recall Terumo APS 1

Manufacturer

Terumo Cardiovascular Systems Corp

Manufacturer Address
Terumo Cardiovascular Systems Corp, 6200 Jackson Rd, Ann Arbor MI 48103-9586
Source
USFDA

20 devices with a similar name

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Device Recall Terumo APS 1

Model / Serial
Serial numbers 0093 and 0104 through 0114.
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide distribution, including USA, Belgium, Germany, Japan, Korea and Republic of China.
Product Description
Terumo Advanced Perfusion System 1; 100V -120V, 15 A (circuit breaker), 50/60 Hz (20A power source required); Models 801763.
Manufacturer
Terumo Cardiovascular Systems Corp

Device Recall Terumo APS 1

Model / Serial
Serial numbers 0040 through 0044.
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide distribution, including USA, Belgium, Germany, Japan, Korea and Republic of China.
Product Description
Terumo Advanced Perfusion System 1; 220V -240V, 7A (circuit breaker), 50/60 Hz (10A power source required); Model 801764. (Not distributed within the United States).
Manufacturer
Terumo Cardiovascular Systems Corp

Device Recall Terumo APS 1

Model / Serial
Serial numbers 0011 through 0039 and 0041 through 0170.
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide, including USA, Belgium, Canada, China, Egypt, Germany, India, Indonesia, Japan, Malaysia, Pakistan, Republic of China, Singapore, South Africa, South Korea and United Arab Emirates.
Product Description
Terumo Advanced Perfusion System 1; 100V -120V, 15 A (circuit breaker), 50/60 Hz (20A power source required) base; Model 801763.
Manufacturer
Terumo Cardiovascular Systems Corp

Device Recall Terumo APS 1

Model / Serial
Serial numbers 0006 through 0066.
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide, including USA, Belgium, Canada, China, Egypt, Germany, India, Indonesia, Japan, Malaysia, Pakistan, Republic of China, Singapore, South Africa, South Korea and United Arab Emirates.
Product Description
Terumo Advanced Perfusion System 1; 220V -240V, 7A (circuit breaker), 50/60 Hz (10A power source required) base; Model 801764. (Not distributed within the United States).
Manufacturer
Terumo Cardiovascular Systems Corp

Device Recall Terumo APS 1

Model / Serial
Serial numbers 0011 through 0363 may be affected. Serial numbers 0011, 0014, 0023, 0038, 0043, 0047, 0119, 0145, 0245, 0253, 0254, 0256, 0260, 0265, 0278, 0280, 0284, 0295, 0305, 0310, 0317, 0333, 0341, 0343, 0351, 0356 and 0360 have been corrected and the other serial numbers listed will be corrected.
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide distribution ---- Nationwide and countries of Australia, Belgium, Canada, Dominican Republic, Egypt, Germany, Hong Kong, India, Indonesia, Japan, Malaysia, Mexico, Pakistan, Philippines, Republic of Georgia, Russia and Saudi Arabia.
Product Description
Terumo Advanced Perfusion System 1; 100V -120V, 15 A (circuit breaker), 50/60 Hz (20A power source required) base; Model 801763.
Manufacturer
Terumo Cardiovascular Systems Corp

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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