GE Healthcare Engstrom Carestation, Engstrom Pro, Cart Only S/5 EC. GE model numbers 1505-8538-000, 1505-9000-000, and 1505-9003-000. Ventilators.
Reported: March 25, 2015 Initiated: January 27, 2015 #Z-1270-2015
Product Description
GE Healthcare Engstrom Carestation, Engstrom Pro, Cart Only S/5 EC. GE model numbers 1505-8538-000, 1505-9000-000, and 1505-9003-000. Ventilators.
Reason for Recall
Potential failure of the caster mounting hardware, which may result in the ventilator falling/tipping (overbalancing).
Details
- Recalling Firm
- GE Healthcare
- Units Affected
- 3,213 (437 US, 2,776 OUS)
- Distribution
- Worldwide Distribution. US nationwide, ALBANIA, ARGENTINA, AUSTRALIA, AUSTRIA, BAHRAIN, BANGLADESH, BELGIUM, BOSNIA & HERZEGOVINA, BRAZIL, CANADA, CAMEROON, CANDA, CHILE, COLOMBIA, COSTA RICA, CROATIA, CZECH REPUBLIC, DENMARK, ECUADOR, EGYPT, EL SALVADOR, FINLAND, FRANCE, GERMANY, CHANA, GREECE, GUATEMALA, HONDURAS, INDIA, INDONESIA, IRAQ, ISRAEL, ITALY, JAPAN, KAZAKHSTAN, KENYA, REPUBLIC OF KOREA, KUWAIT, LEBANON, LIBYAN ARAB JAMAHIRIYA, MACEDONIA, MALAYSIA, MALTA , MEXICO, MOROCCO, NETHERLANDS, OMAN, PANAMA, PAPUA NEW GUINEA, PERU, POLAND, PORTUGAL, QATAR, RUSSIAN FEDERATION, SAUDI ARABIA, SERBIA, SINGAPORE, SLOVAKIA, SOUTH AFRICA, SPAIN, SRI LANKA, SWITZERLAND, SYRIAN ARAB REPUBLIC, THAILAND, TUNISIA, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, VIETNAM, VENEZUELA, and URUGUAY.
- Location
- Waukesha, WI
Frequently Asked Questions
What product was recalled? ▼
GE Healthcare Engstrom Carestation, Engstrom Pro, Cart Only S/5 EC. GE model numbers 1505-8538-000, 1505-9000-000, and 1505-9003-000. Ventilators.. Recalled by GE Healthcare. Units affected: 3,213 (437 US, 2,776 OUS).
Why was this product recalled? ▼
Potential failure of the caster mounting hardware, which may result in the ventilator falling/tipping (overbalancing).
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 25, 2015. Severity: Moderate. Recall number: Z-1270-2015.
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