Recall record at a glance
| Official record | Z-1270-2015 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | GE Healthcare |
| Report date | Mar 25, 2015 |
| Recall initiation date | Jan 27, 2015 |
| Quantity | 3,213 (437 US, 2,776 OUS) |
| Location | Waukesha, WI, United States |
Official 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.
Why the product was recalled
Potential failure of the caster mounting hardware, which may result in the ventilator falling/tipping (overbalancing).
Distribution information
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.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
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