PercuNav Field Generator Stand is a Computed tomography, X-Ray System. Part Number 453561431911. Designed to be used onl
FDA device recall Z-2219-2011 · posted 2011-05-19 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems North America Co. Phillips
- Reason for recall
- The PercuNav Field Generator Stand could tip over during set up, during use, or during transport.
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- JAK
- Quantity affected
- 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.
- Date initiated
- 2011-04-01
- Date posted
- 2011-05-19
- Date terminated
- 2012-03-15
- Location
- Bothell, WA
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Related 510(k) clearances
| Record | Firm | Date |
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| ABARIS (K053610) | Traxtal Technologies, Inc. | 2006-04-19 |