Devices

APS 1

Model / Serial
All units using Power Manager software version 1.10 which includes serial numbers 11 through 339.
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide and worldwide, including Australia, Belgium, Canada, China, Dominican Republic, Egypt, Georgia, Germany, India, Indonesia, Japan, Malaysia, Mexico, Pakistan, Republic of China, Singapore, South Africa, South Korea, Thailand, Turkey and United Arab Emirates.
Product Description
Terumo Advanced Perfusion System 1; 100V -120V, 15 A (circuit breaker), 50/60 Hz (20A power source required); Models 801763 and 801763 (Japan unit).
Manufacturer
Terumo Cardiovascular Systems Corp
1 Event
- Recall of APS 1

Manufacturer

Terumo Cardiovascular Systems Corp

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

63 devices with a similar name

Learn more about the data here

Terumo APS 1

Model / Serial
Serial numbers 0011 through 0395 may be affected.
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution: USA, Australia, Belgium, Canada, Dominican Republic, Egypt, Germany, Hong Kong, India, Indonesia, Japan, Jordan, Malaysia, Mexico, Pakistan, Philippines, Russia, Saudi Arabia, Singapore and South Africa.
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

Terumo APS 1

Model / Serial
Serial numbers 0006 through 0066 and 0100 through 0187 may be affected. Serial numbers 0046 and 0160 have been corrected.
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution: USA, Australia, Belgium, Canada, Dominican Republic, Egypt, Germany, Hong Kong, India, Indonesia, Japan, Jordan, Malaysia, Mexico, Pakistan, Philippines, Russia, Saudi Arabia, Singapore and South Africa.
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

Terumo APS 1

Model / Serial
Serial number range 0033 through 1308 may be affected by this problem. Serial numbers 1060 and 1148 have been corrected.
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide; USA, Australia, Belgium, Canada, Dominician Republic, Egypt, Germany, Hong Kong, India, Indonesia, Japan, Korea, Malaysia, Mexico, Pakistan, Republic of Georgia, Singapore, South Africa, Taiwan, Thailand and United Arab Emirates.
Product Description
Terumo Advanced Perfusion System 1, 6 inch diameter Roller Pump; Model 801041.
Manufacturer
Terumo Cardiovascular Systems Corp

Terumo APS 1

Model / Serial
Serial numbers 0031 through 0324 are potentially affected by the problem. Serial numbers 0092, 0128, 0152, 0223, 0226, 0237, 0246, 0260 and 0296 have been corrected.
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide: USA, Belgium, Canada, Egypt, Germany, Hong Kong, India, Indonesia, Japan, Korea, Malaysia, Singapore and United Arab Emirates.
Product Description
Terumo Advanced Perfusion System 1, 4 inch diameter Roller Pump; Model 801040.
Manufacturer
Terumo Cardiovascular Systems Corp

Terumo APS 1

Model / Serial
Serial numbers 0033 through 0355 are potentially affected by the problem. Serial numbers 0033, 0041, 0049, 0052, 0105, 0115, 0117, 0119, 0122, 0145, 0151, 0159, 0160, 0161, 0162, 0170, 0174, 0218, 0226, 0242, 0257, 0262, 0277, 0279, 0290, 0299, 0300, 0305, 0306, 0331, 0334, 0339, 0343 and 0360 have been corrected.
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide: USA, Belgium, Canada, Egypt, Germany, Hong Kong, India, Indonesia, Japan, Korea, Malaysia, Singapore and United Arab Emirates.
Product Description
Terumo Advanced Perfusion System 1, 6 inch diameter Roller Pump; Model 801041.
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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