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.
This recall has been terminated (originally issued May 19, 2011).
- Recall Initiated
- April 1, 2011
- Posted
- May 19, 2011
- Terminated
- March 15, 2012
- Recall Number
- Z-2219-2011
- Quantity
- 65 units total (33 units distributed to US and 32 units to foreign consignees)
- Firm Location
- Bothell, WA
- Official Source
- View on FDA website ↗
Reason for Recall
The PercuNav Field Generator Stand could tip over during set up, during use, or during transport.
Distribution
Worldwide Distribution -- USA, Australia, Austria, Belgium, China, France, Germany, Hong Kong, India, Korea, Netherlands, Singapore, Sweden, Switzerland, Taiwan, Thailand, and United Kingdom.
Lot / Code Info
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.
Root Cause
Device Design
Action Taken
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.