Terminated

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.

FDA Recall Z-1270-2015 · Posted 2015-03-24

Recalling FirmGE Healthcare

Recall StatusTerminated

Product CodeCBK

Date Initiated2015-01-27

Date Terminated2016-02-03

Product Quantity3,213 (437 US, 2,776 OUS)

Reason for Recall

Potential failure of the caster mounting hardware, which may result in the ventilator falling/tipping (overbalancing).

Firm Action

GE Healthcare sent an Urgent Medical Device Correction letter dated January 26, 2015, Ref#34063. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information. For questions contact GE Healthcare Service at 1-800-437-1171, or your local Service Representative.

Root Cause

Device Design

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K111116ENGSTROM CARESTATION, ENGSTROM PRO, MODELS 1505-9000-000, 1505-9003-000Datex-Ohmeda · 2011-09-09

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.