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Class 2 Device Recall Ingenuity Digital PET/CT |
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| Date Initiated by Firm |
May 21, 2018 |
| Create Date |
July 19, 2018 |
| Recall Status1 |
Terminated 3 on April 10, 2020 |
| Recall Number |
Z-2496-2018 |
| Recall Event ID |
80400 |
| 510(K)Number |
K123599
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| Product Classification |
System, tomography, computed, emission - Product Code KPS
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| Product |
Ingenuity Digital PET/CT System, Model 882446 with the following UDI's:
(01)00884838059559(21)900004
(01)00884838059559(21)900005
(01)00884838059559(21)900006
(01)00884838059559(21)900007
(01)00884838059559(21)900008
(01)00884838059559(21)900009
(01)00884838059559(21)900010
(01)00884838059559(21)900011
(01)00884838059559(21)900012
(01)00884838059559(21)900013
(01)00884838059559(21)900014
(01)00884838059559(21)900015
(01)00884838059559(21)900016
(01)00884838059559(21)900017
(01)00884838059559(21)900018
(01)00884838059559(21)900019
(01)00884838059559(21)900020
(01)00884838059559(21)900021
(01)00884838059559(21)900022
(01)00884838059559(21)900023
(01)00884838059559(21)900024
(01)00884838059559(21)900025
(01)00884838059559(21)900026
(01)00884838059559(21)900027
(01)00884838059559(21)900028
(01)00884838059559(21)900029
(01)00884838059559(21)900030
(01)00884838059559(21)900031
(01)00884838059559(21)900032
(01)00884838059559(21)900033
(01)00884838059559(21)900034
(01)00884838059559(21)900035
Product Usage:
The system is intended to image the whole body, heart, brain, lung, gastrointestinal, bone, lymphatic, and other major organs for a wide range of patient types, sizes, and extent of diseases. Both subsystems can also be operated as fully functional, independent diagnostic tools, including application of the CT scanner for diagnosis and for use in radiation therapy planning.
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| Code Information |
Serial Numbers: 900004 900005 900006 900007 900008 900009 900010 900011 900012 900013 900014 900015 900016 900017 900018 900019 900020 900021 900022 900023 900024 900025 900026 900027 900028 900029 900030 900031 900032 900033 900034 900035 |
Recalling Firm/
Manufacturer |
Philips Medical Systems (Cleveland) Inc
595 Miner Rd
Cleveland OH 44143-2131
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| For Additional Information Contact |
Holly Wright Lee
440-483-7600
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Manufacturer Reason
for Recall |
The block used to connect the patient pallet to the couch may be assembled incorrectly. A screw may be misaligned in the patient pallet.
|
FDA Determined
Cause 2 |
Software design |
| Action |
On May 21, 2018, Philips issued Customer Information notices to their clients. A Philips Field Service Engineer will contact customers directly to schedule the updates at your specific site. If you need any further information or support concerning this issue, please contact your local Philips representative. For SUPPORT in North America and Canada, contact the Customer Care Solutions Center 1-800-722-9377, follow prompts. |
| Quantity in Commerce |
32 units |
| Distribution |
Worldwide Distribution - US Nationwide in the states of CA, GA, LA, MD, MI, NY, OH, TN, TX, VT, Washington DC & WI
Internationally - Canada, Mexico, Belgium, France, Israel, Luxembourg, Netherlands, Singapore, Spain & Switzerland |
| Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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| 510(K) Database |
510(K)s with Product Code = KPS and Original Applicant = PHILIPS HEALTHCARE (CLEVELAND)
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