Philips Medical Systems North America Co. Phillips: 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.

Recall number

Z-2219-2011

Recalling firm

Philips Medical Systems North America Co. Phillips

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.

Status

Terminated

Initiated

2011-04-01

Posted

2011-05-19

Terminated

2012-03-15

Reason

The PercuNav Field Generator Stand could tip over during set up, during use, or during transport.

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

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.

Lot, serial or model codes

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.

510(k) numbers

["K053610"]

PMA numbers

not on file

Product code

JAK

Firm FEI

1000524572

Firm city

Bothell

Firm state

WA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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