Date Initiated by Firm |
October 21, 2022 |
Date Posted |
April 28, 2023 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-1477-2023 |
Recall Event ID |
91979 |
510(K)Number |
K173433 K212837
|
Product Classification |
Interventional fluoroscopic x-ray system - Product Code OWB
|
Product |
Philips ProxiDiagnost N90 1.0 (Model 706100) and ProxiDiagnost N90 1.1 (Model 706110)- A multi-functional general radiography and fluoroscopy (R/F) system |
Code Information |
UDI: (01)00884838085619(21) ProxiDiagnost N90 1.0 (706100);
(01)00884838103221(21) ProxiDiagnost N90 1.1 (706110)
Serial Numbers:
Serial Number
597241
10000000
10000001
10000004
10000005
10000006
10000008
10000009
10000010
10000011
10000012
10000013
10000014
10000015
10000016
10000017
10000018
10000019
10000020
10000021
10000022
10000023
10000024
10000025
10000026
10000027
10000028
10000030
10000031
10000032
10000033
10000034
10000035
10000036
10000037
10000039
10000040
10000041
10000042
10000043
10000044
10000045
10000046
10000047
10000048
10000049
10000050
10000051
10000052
10000053
10000054
10000055
10001013
10001014
10001015
10001017
10001018
10001019
10001020
10001021
10001022
10001023
10001025
10001026
10001028
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10001033
10001035
10001037
10001039
10001040
10001041
10001042
10001043
10001044
10001048
10001049
10001050
10001051
10001053
10001054
10001059
18000001
20000022
20000026
20000034
20000044
20000045
20000046
20000051
20000052
20000054
20000055
20000061
20000062
20000063
20000064
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20000077
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20000079
20000081
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20000085
20000086
20000089
721815121706
SN10001000
SN10001001
SN10001002
SN10001003
SN10001004
SN10001005
SN10001006
SN10001007
SN10001008
SN10001009
SN10001010
SN10001011
SN10001012
SN18000001
SN18000002
SN18000003
SN18000004
SN18000005
SN18000006
SN18000007
SN18000008
SN18000009
SN18000011
SN18000012
SN18000013
SN18000014
SN18000015
SN18000016
SN18000017
SN18000018
SN18000019
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SN18000021
SN18000022
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SN18000024
SN18000152
SN18000249
SN19000001
SN19000002
SN19000003
SN19000004
SN19000005
SN19000006
SN19000007
SN19000008
SN19000009
SN19000010
SN19000011
SN19000012
SN19000013
SN19000014
SN19000015
SN19000016
SN19000017
SN19000018
10001057
10001064
10001059
10001058
10001062
10001069
10001052
10001060
10001070
10001061
10001063
10001068
10001067
10001066
10001073
10001065
10001103
10001075
10001079
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10001074
10001106
10001087
10001088
10001076
10001086
10001093
10001091
10001089
10001100
10001099
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10001078
10001098
10001102
10001105
10001072
10001096
10001090
10001077
10001118
10001109
10001110
10001107
10001112
10001092
10001111
10001113
10001101
10001116
10001108
10001045
10001055
10001083
10001095
10001094
10001071
10001082
10001080
|
Recalling Firm/ Manufacturer |
Philips North America Llc 222 Jacobs St Cambridge MA 02141-2289
|
For Additional Information Contact |
Customer Care Solution Center 800-722-9377
|
Manufacturer Reason for Recall |
Potential table stop due to a broken tabletop cable:
On the ProxiDiagnost N90 table there is a cable located under the tabletop that is covered by a plastic sleeve which can crack and damage the cable. If the tabletop cable breaks, the user may not be able to initiate table tilting movements or braking
|
FDA Determined Cause 2 |
Component design/selection |
Action |
Philips issued a revised customer letter on 3/10/23 via U.S. mail -URGENT Medical Device Correction Notification Update CombiDiagnost R90 and ProxiDiagnost N90 Component damage due to short circuit & table stop due to broken tabletop cable. Customers received previous customer communications : 21 Oct 2021 for ProxiDiagnost N90 1.0 (706100); 17 Nov 2022 for ProxiDiagnost N90 1.1 (706110).
Circulate this notice to all users of the device, attach the notice as an addendum to the IFU (User Manual).
If a user observes fire in the M-cabinet, sees or smells smoke, or hears a popping noise coming from the M-cabinet, immediately remove power to the room, remove the
patient, stop using the system for further examinations. Follow local fire regulations (e.g. evacuation, inform firefighters). Contact Customer Care Solutions Center (1-800-722-9377), reference FCO70900054 (CombiDiagnost R90), FCO70600105 (ProxiDiagnost N90 1.0), or FCO70600108 (ProxiDiagnost N90 1.1) to arrange for a Philips Field Service Engineer to visit your site. (FSE) will visit impacted customer sites to update the system with a hardware component to prevent the issue from occurring.
If the table is not tilting or braking as expected:
Bring the table back to 0degree position using the Tilting Switch, remove the patient from table, stop using the system for further examinations. Contact Customer Care Solutions Center (1-800-722-9377), reference FCO70600105 (ProxiDiagnost N90 1.0) or FCO70600108 (ProxiDiagnost N90 1.1) to arrange for a Philips Field Service Engineer to visit your site to inspect and fix the cable.
|
Quantity in Commerce |
Total Quantity: 234 units. US 195units. R.O.W 39 units |
Distribution |
Worldwide distribution - US Nationwide including Puerto Rico and the countries of Australia, Chile, China, Germany, India, Italy, Malaysia, Netherlands, Panama, Spain,
Thailand.
|
Total Product Life Cycle |
TPLC Device Report
|
|
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.
|
510(K) Database |
510(K)s with Product Code = OWB and Original Applicant = Philips Medical Systems DMC GmbH
|