| Class 2 Device Recall Allura Xper R8.x.25.5 (only with a FlexVision large screen monitor) |  |
Date Initiated by Firm | March 14, 2018 |
Create Date | May 01, 2018 |
Recall Status1 |
Terminated 3 on April 29, 2024 |
Recall Number | Z-1589-2018 |
Recall Event ID |
79770 |
510(K)Number | K133292 |
Product Classification |
Interventional fluoroscopic x-ray system - Product Code OWB
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Product | Allura Xper R8.x.25.5 and UNIZ systems (only with a FlexVision large screen monitor), Interventional fluoroscopic x-ray system
Product Usage:
The Allura Xper ED series is intended for use on human patients to perform: Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures. This includes, eg peripheral, cerebral, thoracic and abdominal angiography, as well as PTAs, stent placement, embolization and thrombolysis. Cardiac imaging applications including diagnostics, interventional minimally invasive procedures (such as PTCA, stent placing, atherectomies), pacemaker implantations, and electrophysiology (EP). Non-vascular interventions such as drainages, biopsies and vertebroplasties procedures. Additionally: The Allura Xper ED series is compatible with a hybrid operating room. |
Code Information |
Product name: Allura Xper R8.1 .25.0 Allura Xper R8.1 .25.1 Allura Xper R8.1 .25.5 Allura Xper R8.2.25.0 Allura Xper R8.2.25.5 Allura Xper R8.2.27 UNIQ Ri .0.10 UNIQ Ri .0.10.5 Product code: 722003, 722005, 722006, 722008, 722010, 722011, 722012, 722013, 722014, 722015, 722019, 722020, 722022, 722023, 722024, 722025, 722026, 722027, 722028, 722029, 722033, 722034, 722035, 722036, 722038, 7322039, 722058, 722059. |
Recalling Firm/ Manufacturer |
Philips Electronics North America Corporation 3000 Minuteman Rd Andover MA 01810-1032
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For Additional Information Contact | 978-659-3000 |
Manufacturer Reason for Recall | After continuous operation for more than one and a half days, the image on the large screen monitor may freeze for approximately 15 seconds after which the system will restore itself. |
FDA Determined Cause 2 | Software design |
Action | Field Safety Notices were distributed on 3/14/18. The notices instructed customers:
To prevent occurrence of the issue customers shall restart the system at least once a day.
Customer shall ensure that all staff with access to the affected systems are informed of the contents of this Field Safety Notice.
A copy of this Field Safety Notice shall be placed together with the documentation of the system until the system has been corrected by Philips.
The problems will be resolved by a software update, which is expected to be available by the second half of 2018.
You will be notified by your local Philips representative when the software update is available for installation.
If you need any further information or support concerning this issue, please contact your local Philips representative: Technical Support Line: 1-800-722-9377, 8am to 8pm (EST) Monday thru Friday. |
Quantity in Commerce | 682 |
Distribution | Worldwide Distribution in the states of: AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, PA, SC, TN, TX, UT, VA, VT, WA, WI, WV, and WY.
The product was distributed to the following countries: Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Croatia, Cuba, Czech Republic, Denmark, Estonia, France, Germany, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Kazakhstan, Republic of Korea, Malaysia, Mexico, Morocco, Myanmar, Netherlands, New Caledonia, Norway, Pakistan, Poland, Qatar, Romania, Russia, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, and United Kingdom. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = OWB
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