SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULE (Marketed As GE Healthcare CARESCAPE Patient Data…

Date

Jan. 15, 2014

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

SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULE (Marketed As GE Healthcare CARESCAPE Patient Data Module)

Reason

GE Healthcare has recently become aware of a potential safety issue which affects all Patient Date Modules produced from April 2007 through June 2010, encompassing Fiscal Week 13, 2007 through 26, 2010 due to fluid ingress into the top cover assembly which can result in heat buildup.

Distribution pattern

Worldwide Distribution: US (nationwide) including states of: AL, AZ, AR, CA, CO, CT, DC, FL, GA, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, O, NE, NV,NH, NJ, NM, NY, NC, OH, OK, OR,PA PR, RI,SC, TN, TX, UT, VT, VA, WA, WI, and WY. Internationally to: ARGENTINA, AUSTRALIA, AUSTRIA, BANGLADESH, BELGIUM, BRAZIL, CANADA, CHILE, CHINA, COLOMBIA, CZECH REPUBLIC, DENMARK, EGYPT, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, GUATEMALA, INDIA, INDONESIA, IRELAND, ISRAEL, ITALY, JAMAICA, JAPAN, JORDAN, REPUBLIC OF KOREA, KUWAIT, LEBANON,LITHUANIA, MALAYSIA, MAURITIUS, MOROCCO, NETHERLANDS, NEW ZEALAND, NORWAY, POLAND, QATAR , SAUDI ARABIA, SINGAPORE, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TRINIDAD AND TOBAGO, TUNISIA, TURKEY, UNITED ARAB EMIRATES, and UNITED KINGDOM.

Quantity

17,444 (11,418 units US, 6,026 units OUS).

Codes and lots

Mfg Lot or Serial # SA307140598GA SA307140599GA SA307140600GA SA307140601GA SA307140605GA SA307140606GA SA307140607GA SA307140610GA SA307140611GA SA307140612GA SA307140614GA SA307140615GA SA307140618GA SA307140619GA SA307140622GA SA307140623GA SA307140627GA SA307140628GA SA307140631GA SA307140632GA SA307140636GA SA307140637GA SA307140639GA SA307140640GA SA307140641GA SA307140642GA SA307140644GA SA307150645GA SA307150646GA SA307150655GA SA307150656GA SA307020391GA SA307030405GA SA307030424GA SA307070446GA SA307070447GA SA307070448GA SA307080462GA SA307080463GA SA307080484GA SA307080508GA SA307080523GA SA307110548GA SA307110556GA SA307110571GA SA307190716GA SA307190737GA SA307190739GA SA307190750GA SA307190768GA SA307020379GA SA307020384GA SA307020386GA SA307030407GA SA307030409GA SA307030412GA SA307030414GA SA307060432GA SA307070436GA SA307070440GA SA307070441GA SA307070442GA SA307070450GA SA307070453GA SA307070454GA SA307070455GA SA307080472GA SA307080477GA SA307080478GA SA307080504GA 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SA307302076GA SA307302077GA SA307302078GA SA307302079GA…

Recall started

Dec. 16, 2013

Device type

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

Root cause (FDA)

Nonconforming Material/Component

What the company told customers

Consignees were sent on 12/16/2013 a GE Healthcare "Urgent Medical Device Correction" letter dated December 5, 2013. The letter was addressed to Healthcare Administrator / Risk Manger, Chief of Nursing and Director of Biomedical Engineering. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information (Contact Technical Support at 1-800-558-7044 or your local Service Representative).

Recall number

Z-0648-2014

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

Source: FDA · Medical device enforcement report, recall number Z-0648-2014. The agency record governs; check it and the company before acting.