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U.S. Department of Health and Human Services

Class 2 Device Recall PercuNav Field Generator Stand

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 Class 2 Recall
PercuNav Field Generator Stand
see related information
Date Posted May 19, 2011
Recall Status1 Terminated on March 15, 2012
Recall Number Z-2219-2011
Recall Event ID 58429
Premarket Notification
510(K) Number
K053610 
Product Classification System, X-Ray, Tomography, Computed - Product Code JAK
Product PercuNav Field Generator Stand is a Computed tomography, X-Ray System. Part Number 453561431911. Designed to be used only with the PercuNav" image guided intervention system. The Field Generator Stand (with articulating Mounting Arm) is used to position the Field Generator near the area of interest.
Code Information System Code Serial Numbers: 03B8Y3, 20071000005, 20071000006, 20071000007, 20071000008, 20071000009, 20071000010, 20081000011, 20081000013, 20091000019, 20091000020, 20091000021, 20091000022, 20091000023, 02RCHF, 02X3NK, 034K1R, 039VDK, 039W1H, 03B4F3, 03B59R, 03B8MW, 03B8N0, 03B8QR, 03B8XX, 03B8XY, 03B8XZ, 03B8Y0, 03B8Y1, 03B8Y4, 03B8Y5, B0091T, B009BJ, B009HV, B009VJ, B00DDJ, B00DQ2, B00DQX, B00DQZ, B00DRF, B00DRP, B00DT7, B00DXM, B00DY0, B00F1Q, B00F3H, B00F3M, B00HKW, B00HKZ, B00HV4, B00HV7, B00HW3, B00HZR, B00J05, B00P3X, B00P3Y, B00P59, B00P5P, B00PB4, B00PJJ, B00PPP, B00PQ7, and P002A20090500005.
Recalling Firm/
Manufacturer
Philips Medical Systems North America Co. Phillips
22100 Bothell Everett Hwy
Bothell, Washington 98021-8431
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact Philips Customer Service
425-487-7602
Manufacturer Reason
for Recall
The PercuNav Field Generator Stand could tip over during set up, during use, or during transport.
FDA Determined
Cause 2
DESIGN: Device Design
Action On 4/4/11, Philips Healthcare began sending out the URGENT-Medical Device Correction notification letter to their consignees. Philips informed their customers of a potential tipping hazard of the PercuNav Field Generator Stand. The notification letter also provides instructions to customers to ensure the articulating Mounting Arm is positioned so the Field Generator is not further than the specified distance from the back of the clamp on the stand's central pole during set up or during use. Customers are instructed to apply a provided label on stand to warn of a potential for tipping due to excessive force. For transport, customers are instructed to remove the Field Generator from the Mounting Arm and place the Field Generator in the storage compartment on the system cart. The Mounting Arm should then be collapsed and folded into a 90 degree angle. Customers are informed that a Philips field service representative will contact them to schedule installation of a service kit on the stand, free of charge, once service kits are available. Customers can call Philips Customer Service at 1-866-767-7822 and reference to FCO 79500197 for any questions about this recall.
Quantity in Commerce 65 units total (33 units distributed to US and 32 units to foreign consignees)
Distribution Worldwide Distribution -- USA, Australia, Austria, Belgium, China, France, Germany, Hong Kong, India, Korea, Netherlands, Singapore, Sweden, Switzerland, Taiwan, Thailand, and United Kingdom.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = JAK and Original Applicant = TRAXTAL TECHNOLOGIES INC.
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