| | Class 2 Device Recall Philips |  |
| Date Initiated by Firm | May 01, 2021 |
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| Create Date | June 30, 2021 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-1985-2021 |
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| Recall Event ID |
87974 |
| 510(K)Number | K193454 |
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| Product Classification |
System, x-ray, tomography, computed - Product Code JAK
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| Product | Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor
728332 - IQon Spectral CT
: IQon Spectral CT |
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| Code Information |
Model/ Serial Number/UDI: N/A 728332 860005 N/A 728332 395001 N/A 728332 860043 (01)00884838059542(21)860043 728332 860131 (01)00884838059542(21)860131 728332 860050 (01)00884838059542(21)860050 728332 860122 (01)00884838059542(21)860122 728332 60038 (01)00884838059542(21)60038 728332 860177 N/A 728332 860185 (01)00884838059542(21)860185 728332 860172 (01)00884838059542(21)860172 728332 60051 (01)00884838059542(21)60051 728332 60009 N/A 728332 860098 (01)00884838059542(21)860098 728332 60054 (01)00884838059542(21)60054 728332 860199 (01)00884838059542(21)860199 728332 860123 (01)00884838059542(21)860123 728332 860059 (01)00884838059542(21)860059 728332 860199 N/A 728332 860015 N/A 728332 860014 N/A 728332 860096 (01)00884838059542(21)860096 728332 860029 N/A 728332 860073 (01)00884838059542(21)860073 728332 860058 (01)00884838059542(21)860058 728332 860082 (01)00884838059542(21)860082 728332 860069 (01)00884838059542(21)860069 728332 860216 (01)00884838059542(21)860216 728332 860193 (01)00884838059542(21)860193 728332 860118 (01)00884838059542(21)860118 728332 860024 N/A 728332 860204 (01)00884838059542(21)860204 728332 60066 N/A 728332 860154 N/A 728332 860175 (01)00884838059542(21)860175 728332 860186 (01)00884838059542(21)860186 728332 860038 N/A 728332 860078 (01)00884838059542(21)860078 728332 60042 (01)00884838059542(21)60042 728332 860110 (01)00884838059542(21)860110 728332 860027 (01)00884838059542(21)860027 728332 860071 (01)00884838059542(21)860071 728332 860139 (01)00884838059542(21)860139 728332 60014 (01)00884838059542(21)60014 728332 N/A 728332 60040 (01)00884838059542(21)60040 728332 860153 (01)00884838059542(21)860153 728332 860103 (01)00884838059542(21)860103 728332 860075 (01)00884838059542(21)860075 728332 860181 (01)00884838059542(21)860181 728332 860012 N/A 728332 860046 (01)00884838059542(21)860046 728332 860152 (01)00884838059542(21)860152 728332 860054 (01)00884838059542(21)860054 728332 860140 (01)00884838059542(21)860140 728332 860020 N/A 728332 860130 (01)00884838059542(21)860130 728332 860147 (01)00884838059542(21)860147 728332 860061 (01)00884838059542(21)860061 728332 860079 (01)00884838059542(21)860079 728332 860218 (01)00884838059542(21)860218 728332 860149 (01)00884838059542(21)860149 728332 860064 (01)00884838059542(21)860064 728332 860121 (01)00884838059542(21)860121 728332 860109 (01)00884838059542(21)860109 728332 60032 (01)00884838059542(21)60032 728332 860200 (01)00884838059542(21)860200 728332 860041 (01)00884838059542(21)860041 728332 860160 N/A 728332 860090 (01)00884838059542(21)860090 728332 860035 (01)00884838059542(21)860035 728332 860057 (01)00884838059542(21)860057 728332 860017 N/A 728332 860203 (01)00884838059542(21)860203 728332 860008 N/A 728332 860128 (01)00884838059542(21)860128 728332 860129 (01)00884838059542(21)860129 728332 860158 N/A 728332 860209 (01)00884838059542(21)860209 728332 860211 (01)00884838059542(21)860211 728332 60029 (01)00884838059542(21)60029 728332 860183 (01)00884838059542(21)860183 728332 860013 N/A 728332 860091 (01)00884838059542(21)860091 |
Recalling Firm/
Manufacturer |
Philips North America Llc
222 Jacobs St
Cambridge MA 02141-2289
|
Manufacturer Reason
for Recall | Significant wear of the Monitor Bracket Assembly shaft goes unrecognized could potentially lead to the Monitor Bracket Assembly detaching from the Suspension Arm and result in potential hazard for the monitor to fall while remaining attached to the
cables resulting in patient, operator, bystander, or service person to serious injury. |
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FDA Determined
Cause 2 | Device Design |
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| Action | Philips issued URGENT- Field Safety Notice Medical Device Correction letter on 5/1/21 FSN 72800751 and FSN 88200530 . Letter states reason for recall, health risk and action to take: " Be aware of this hazard when the safety clip is missing from the joint assembly between the Monitor Bracket Assembly and the Ceiling Suspension Arm.
" Inspect the joint area of their CCT DVI Ceiling Mount Arm (the circled area in picture at theright) and observe that the safety clip is installed (as depicted in pictures below).
" When this hazard occurs, the monitor may become difficult to rotate relative to the Suspension Arm.
When these symptoms are recognized, in order to avoid the occurrence of a hazardous situation, take the following actions:
stop using the suspension monitor clinically
move the monitor arm away from any person
call Philips Service for repairs.
Please acknowledge the receipt of this notice by completing, signing, and returning the form attached at the end of this communication to the indicated email address.
Philips will inspect systems via Field Change Order FCO 88200530. Systems failing the inspection will be corrected via Field Change Order FCO 882531
For North America, contact the Customer Care Solutions Center (1-800-722-9377, follow the prompts). |
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| Quantity in Commerce | 1,301 Monitor Bracket Assemblies total |
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| Distribution | Worldwide distribution - US Nationwide and the countries of Canada, Mexico, AE, AR, AT, AU, BD, BE, BR, CH, CL, CN, CO, CU, CY, CZ, DE, DK, DZ, EE, EG, ES, FI, FR, GB, GE, GI, GL, GR, HK, HU, ID, IE, IL, IN, IQ, IR, IT, JO, JP, KE, KG, KH, KR, LA, LB, LK, LT, LY, MM, MN, MU, MV, MY, NI, NL, NO, NZ, OM, PA, PF, PH, PK, PL, PS, PT, QA, RE, RU, RW, SA, SE, SG , SI, SK, TH, TN, TR, UZ, VN, XK, YE, ZA, ZW. |
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| 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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| 510(K) Database | 510(K)s with Product Code = JAK
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