2013年7月30日 星期二

一級召修 GE Healthcare Nuclear Medicine Systems


(http://bme.freebbs.tw 醫學工程論壇同步發表)



GE Healthcare Nuclear Medicine Systems

Brivo NM615  "奇異"核醫影像系統 奇異亞洲醫療設備股份有限公司 *** 衛署醫器輸字第024268號 ***

Recall Class:  Class I
Date Recall Initiated: June 13, 2013
Products: Infinia Nuclear Medicine Systems, VG and VG Hawkeye Nuclear Medicine Systems, Helix Nuclear Medicine Systems, Brivo NM615, Discovery NM630, Optima NM/CT640, Discovery NM/CT670
Models: Infinia 3/8, Infinia-II 3/8, Infinia VC, Infinia II VC, Infinia 3/8 Hawkeye, Infinia VC Hawkeye, Infinia II 3/8 Hawkeye, Infinia II VC Hawkeye, Infinia II 3/8 HE4, Infinia II 5/8 HE4, Infinia II VC HE4, Varicam, Millennium VG 3/8, Millennium VG 5/8, Millennium VG 3/8 Hawkeye, Millennium VG 5/8 Hawkeye, Discovery VH, Helix nuclear medicine systems, Brivo NM615, Discovery NM630, Optima NM/CT640, Discovery NM/CT670
These affected products were distributed from October, 1992 through June, 2013.
Use:  These Nuclear Medicine systems are used to perform general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient's body, using a variety of scanning modes supported by various acquisition types and optional imaging features designed to enhance image quality in Oncology, Cardiology, Neurology and other clinical diagnostic imaging applications. The scanning modes include planar (Static, Multi-gated, Dynamic, Whole body scanning) and tomographic (SPECT, Gated SPECT, Whole body SPECT, Camera based PET - also known as Coincidence Detection). Acquisition types include single and multi-isotope/multi-peak frame/list mode single-photon and positron imaging. Optional imaging-enhancement features include assortment of collimators, gating by physiological signals, real-time automatic body contouring, and CT-based attenuation correction and functional anatomic mapping.

Recalling Firm:
GE Healthcare, LLC
3000 N Grandview Blvd.
Waukesha WI 53188-1615

Manufacturer: 
GE Medical System Israel Ltd
4 Hayozma St.
Tirat Hacarmel, Israel

Reason for Recall: GE Healthcare became aware of an incident at a VA Medical Center facility in the US. A patient died due to injuries sustained while being scanned on an Infinia Hawkeye 4 Nuclear Medicine System. On July 03, 2013 GE notified hospitals that they were recalling several Nuclear Medicine Imaging Systems because serious injuries or deaths could occur due to the failure mode associated with this recall. GE advised hospitals that they cease use of their Nuclear Medicine systems until GE can complete an inspection of the system. In the second notification, GE included all Nuclear Medicine Systems.

Bolts securing the camera to the gantry were loose, thereby stressing thesupport mechanism and resulting in the incident.   
因在Gantry上的攝影機固定螺栓鬆脫,擠壓支撐機構,造成意外事件。
from  Urgent Medical Device Recall3 letter

Public Contact: For questions about this recall contact GE Healthcare Service Representative at 1-800-437-1171

FDA District: Minneapolis District Office

FDA Comments:
On June 17, 2013 GE sent an Urgent Medical Device Correction letter to all affected customers. The letter identified the affected product, recommended that qualified service personnel maintain the equipment and that Preventative Maintenance procedures were executed according to labeling. In addition, the Safety Chapter Sections should be re-reviewed with personnel to ensure proper operation of the equipment.
On July 03, 2013 GE notified customers again via an Urgent Medical Device Recall1 letter (including confirmation of delivery for US customers) and follow-up telephone calls. Healthcare facilities are instructed to cease use of their Nuclear Medicine system until a GE Healthcare Field Engineer is able to do a complete inspection of the system and perform any necessary repairs at no cost. A GE Healthcare representative will contact the hospitals to arrange for the inspection.
Physicians: No action is required beyond the recommendations provided in the Urgent Medical Device Recall letter.
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to MedWatch: The FDA Safety Information and Adverse Event Reporting Program2 either online, by regular mail or by FAX.
Additional Links

2013年7月18日 星期四

Stryker Infinite No Power

(http://bme.freebbs.tw 醫學工程論壇同步發表)


名稱: Stryker Infinite 微創影音交換主機

故障情形:No Power
故障原因:電源整流IC(TOP 246GN)擊穿

這台是Stryker Infinite 微創影音交換主機,狀況是無法開機,同事猜測是Power故障,就把整台上半部拆回來,也剛好還有一台會議用的,可以先拆去擋著用,所以檢修時間上較不會那麼趕。

拆開Power模組,裡面有三大塊電路板,既然是Power故障,同事就開始標準的"望、聞、問、切";

看哪有焦味及焦黑的痕跡,把電路板翻開,Bingo!一顆IC擊穿了,還好碎片還在附近,組合回去,是TOP246GN,拜一下Google大神,原來是一個整流(regulator)的電源IC,應該不難找吧。

















在拍賣上再找了一下,只有246PN,差了一個型號,確認了Datasheet,原來GN是SMD封裝,PN是DIP腳座封裝,規格都一樣,耐壓及瓦數都相同(15/26W)。

因為既然是被擊穿,有可能是IC本身問題,或是後級的問題,保險起見就買3 顆吧,反正如果真是後級或負載造成,沒裝上去也不知道啊,打壞1個,還有2個,很幸運的,是IC本身問題,所以換了就OK,還剩2個當備料囉。