510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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Z-2219-2011

PercuNav Field Generator Stand is a Computed tomography, X-Ray System. Part Number 453561431911. Designed to...

Philips North America LLC / initiated 2011-04-01 / Terminated / root cause: design
FDA source (opens on fda.gov)

Philips Medical Systems North America Co. Phillips began a recall of PercuNav Field Generator Stand is a Computed tomography, X-Ray System. Part Number 453561431911. Designed to be used only with the PercuNav" image guided... on . The reason FDA records is "The PercuNav Field Generator Stand could tip over during set up, during use, or during transport". As of , the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number
Z-2219-2011
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Philips North America LLC
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.
Product code
JAK System, X-Ray, Tomography, Computed
Reason for recall
The PercuNav Field Generator Stand could tip over during set up, during use, or during transport.
Root cause tag
design
FDA root cause
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.
Product codes and lots
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.