Events

Rappel de Device Recall BrightView SPECT

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Philips Medical Systems (Cleveland) Inc.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    76716
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1750-2017
  • Date de mise en oeuvre de l'événement
    2017-02-24
  • Date de publication de l'événement
    2017-04-06
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2018-07-02
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=154006
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    System, tomography, computed, emission - Product Code KPS
  • Cause
    The brake hub was not engaging with the gear box shaft due to an error in the assembly of components within the brake hub mechanism after service, causing the detector to backdrive.
  • Action
    Philips Healthcare sent an Urgent Field Safety Notice letter informing consignees of the issue through: Field Safety Notice (FSN) CLE17-006_88200502_88200503. Customers will be notified by direct communication from Philips Field Service Engineers (FSE). A copy of the FSN will be provided to customers by the FSE during the onsite visit for the inspection. A Business Reply form is attached to the FSN for customers to acknowledge receipt and understanding of the FSN. Customers with questions were instructed to contact the Customer Care Solutions Center at 1-800-722-9377. For questions regarding this recall call 440-483-7600.

Device

Device Recall BrightView SPECT
  • Modèle / numéro de série
    4000008, 4000287, 4000497, 4000364, 4000346, 4000557, 4000423, 4000088, 4000029, 4000631, 4000339 , 4000072, 4000643, 4000640, 4000420, 4000543, 4000010, 4000282, 4000216, 4000415, 4000208, 4000322, 4000406, 4000434, 4000241, 4000055, 4000117, 4000200, 4000138, 4000352, 4000509, 4000362, 4000598, 4000433, 4000178, 4000473, 4000271, 4000357, 4000258, 4000060, 4000528, 4000099, 4000192, 4000079, 40000101, 4000310, 4000214, 4000671, 4000050, 4000349, 4000658, 4000308, 4000215, 4000384, 4000263, 4000074, 4000255, 4000633, 4000098A, 4000251, 4000446, 4000680, 4000095, 4000424, 4000508, 4000603, 4000347, 4000113, 4000668, 4000703001, 4000140, 4000367, 4000037, 4000426, 4000440, 4000391, 4000177, 4000482, 4000162, 4000083, 4000501, 4000505, 4000317, 4000174
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution - US including AZ, CA, CO, CT, FL, GA, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NJ, NY, OH, OR, PA, TN, TX, VA, WA, WI, and WV. Internationally to Australia, Austria, Belgium, Brazil, Canada, Chile, China, Denmark, Egypt, France, Germany, India, Israel, Italy, Japan, Mexico, Republic of Korea, Malaysia Netherlands, Philippines, Poland, Portugal, Russian Federation, Saudi Arabia, South Africa, Spain, Switzerland, Taiwan, UAE, and UK. There are eleven (11) government accounts for this recall: Edward Hines Jr VA Hospital, 5th Ave & Roosevelt Rd, Hines, IL 60141; VA Jessie Brown OPC, 2030 W Taylor St, Chicago, IL 60612; VA Medical Center, 4300 W 7th St, Little Rock, AR 72205; VA Medical Center, 2200 SW Gage Blvd, Topeka, KS 66622; VA Medical Center, 2501 W 22nd St, Sioux Falls, SD 57105; VA Medical Center, 3600 30th St, Des Moines, IA 50310; VA Medical Center, 2300 Ramsey St, Fayetteville, NC 28301; VA Medical Center Durham, 508 Fulton St, Durham, NC 27705; VA Medical Center of Orlando, 13800 Veterans Way, Orlando, FL 32827; Veterans Hospital, 1 Veterans Dr, Minneapolis, MN 55417; Womack Army Medical Center, Reilly Rd, Fort Bragg, NC 28307. There are thirteen (13) Canada accounts for this recall: CAMPHILL SITE, 1796 SUMMER ST, HALIFAX, NOVA SCOTIA B3H 3A7; COR CARE INC, 325 MILNER AVE STE 410, SCARBOROUGH, ONTARIO M1B 5N1; CSSS DE RIMOUSKI-NEIGETTE, ROUL¿AU 150, RIMOUSKI, QUEBEC G5L 5T1; FOOTHILLS MEDICAL CENTRE, 1403 29 ST NW, CALGARY, ALBERTA T2N 2T9; HEADWATERS HEALTH CENTRE, 100 ROLLING HILLS DR, ORANGEVILLE, ONTARIO L9W 4X9; HEALTH SCIENCES NORTH, 41 RAMSEY LAKE RD, SUDBURY, ONTARIO P3E 5J1; MEDICAL IMAGING CONSULTAN, 200 BOUDREAU RD STE 102 ST., ALBERT, ALBERTA T8N 6B9; NORTH BAY REGIONAL HEALTH, 50 COLLEGE DR, NORTH BAY, ONTARIO P1B 0A4; PETERBOROUGH REGIONAL HEA, 1 HOSPITAL DR, PETERBOROUGH, ONTARIO K9J 7C6; ROCKY VIEW GENERAL HOSPIT, 7007 14 ST SW, CALGARY, ALBERTA T2V 1P9; ROYAL VICTORIA HEALTH CEN, 201 GEORGIAN DR, BARRIE, ONTARIO L4M 6M2; SOUTHERN ALBERTA INS. TEC, 1301 16 AVE NW, CALGARY, ALBERTA T2M 0L4; WOODSTOCK HOSPITAL, 310 JULIANA DR, WOODSTOCK, ONTARIO N4V 0A4. There is one (1) Mexico account for this recall: Arrendadora Medica Galena, AV Tulum#MZ 1LT 1#SM 12, Benito Juarez, Quintana Roo, 77505.
  • Description du dispositif
    BrightView SPECT model number 882480 || BrightView and BrightView X are gamma cameras designed for single or dual detector nuclear imaging accommodating a broad range of Emission Computed Tomography (ECT) studies. The cameras can be used to perform planar static, dynamic, gated, and total body studies, as well as circular-orbit and noncircular orbit SPECT studies, gated SPECT (circular and noncircular)studies, computer-programmed protocol strings, and reference scans (dual detectors only).
  • Manufacturer
    Philips Medical Systems (Cleveland) Inc

Manufacturer

Philips Medical Systems (Cleveland) Inc
  • Adresse du fabricant
    Philips Medical Systems (Cleveland) Inc, 595 Miner Rd, Cleveland OH 44143-2131
  • Société-mère du fabricant (2017)
    Philips
  • Source
    USFDA