GE Healthcare…

Date

Feb. 20, 2013

Risk class

Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)

Status

Terminated

Filed by

GE Healthcare, LLC

Product

GE Healthcare, CARESCAPE Monitor B650. The CARESCAPE Monitor B650 is a multi-parameter patient monitor intended for use in multiple areas and intra-hospital transport within a professional healthcare facility. The CARESCAPE Monitor B650 is intended for use on adult, pediatric, and neonatal patients and on one patient at a time.

Reason

GE Healthcare has become aware of potential issues associated with the CARESCAPE Monitor B650. There have been no reported illnesses or injuries that have occurred with the use of the device.

Distribution pattern

Worldwide Distribution - USA including AL, AZ, AR, CA, CO, CT, FL, GA,IL,IN, IA, KS, KY,LA, MD, MA, MI, M, MO, NE, NE,NJ, NM, NY, NC, OH, OK PA, SC, TN, TX, UT, VA, WI. Internationally to UNITED KINGDOM, UNITED ARAB EMIRATES, TURKEY, THAILAND, SWITZERLAND, SWEDEN, SPAIN, SOUTH AFRICA, SLOVENIA, SLOVAKIA, SINGAPORE, SAUDI ARABIA, ROMANIA, PORTUGAL, POLAND, PERU, NORWAY, NEW ZEALAND, NETHERLAND, MALAYSIA, LITHUANIA, KUWAIT, JAPAN, ITALY, ISRAEL, IRELAND, INDIA, ICELAND, HONG KONG, GERMANY, FRANCE, FINLAND, EGYPT, DENMARK, CZECH REPUBLIC, COLOMBIA, CHILE, CANADA, BELGIUM BAHRAIN, AUSTRIA, AUSTRALIA.

Quantity

2813

Codes and lots

SERIAL NUMBER SEW1181782HA SEW11243524HA SEW11223123HA SEW11223122HA SEW11223121HA SEW11223108HA SEW11223107HA SEW11223106HA SEW11223092HA SEW11223086HA SEW11223085HA SEW11223082HA SEW11223070HA SEW11223022HA SEW11223019HA SEW11223011HA SEW11222999HA SEW11222997HA SEW11202780HA SEW11202778HA SEW11202775HA SEW11202753HA SEW11202750HA SEW11202749HA SEW11202746HA SEW11202745HA SEW11202744HA SEW11202742HA SEW11202741HA SEW11202740HA SEW11202739HA SEW11202737HA SEW11202736HA SEW11202717HA SEW11202716HA SEW11202715HA SEW11202713HA SEW11202712HA SEW11202711HA SEW11202709HA SEW11202708HA SEW11202706HA SEW11202705HA SEW11202704HA SEW11202703HA SEW11202702HA SEW11202700HA SEW11202697HA SEW11202690HA SEW11202687HA SEW11202682HA SEW11202401HA SEW11202400HA SEW11202399HA SEW11202398HA SEW11202397HA SEW11202395HA SEW11202394HA SEW11202390HA SEW11202385HA SEW11202384HA SEW11202383HA SEW11202381HA SEW11202379HA SEW11202378HA SEW11202370HA SEW11202369HA SEW11202368HA SEW11202366HA SEW11202363HA 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SEW11100002HA SEW11079544HA SEW11202326HA SEW11202324HA SEW11202318HA…

Recall started

Sept. 30, 2011

Device type

Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

Root cause (FDA)

Software design

What the company told customers

GE Healthcare sent an Important Product Notification letteron September 30, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to keep the patient under close observation or use an alternate monitoring device. Customers should not disconnect the affected USB devices from the patient monitor during an active patient case. If the license is enabled, the alarm limit adjustments from the iCentral Client has an L-NETM-00 license should be disabled. GE Healthcare would contact customers to schedule the update. Customers with questions should contact Technical Support or their local representative. For questions regarding this recall call 262-513-4122.

Recall number

Z-0823-2013

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement report, recall number Z-0823-2013. The agency record governs; check it and the company before acting.