Class II Recall

ProxiDiagnost N90- A Multi-functional general Radiography and Fluoroscopy (R/F) system Ref: (1)706100 (2)706110

Summary

The FDA issued a Class II for ProxiDiagnost N90- A Multi-functional general Radiography and Fluoroscopy (R/F) by Philips North America. Reason: Issue 1: Mixed Images: The Radio Fluoroscopy (RF) viewer may also display a previous patient s radiography (RAD) images when starting the next patient.

Details

Source

Device Recall

External ID

Z-1072-2024

Action Date

2024-02-21

Status

Ongoing

Product Description

ProxiDiagnost N90- A Multi-functional general Radiography and Fluoroscopy (R/F) system Ref: (1)706100 (2)706110

Lot/Code Info: UDI: (1) 00884838085619 (2) 00884838103221 UDI: (1) 00884838085619 (2) 00884838103221 Serial Numbers US: (1) 10001064 10001065 10001066 10001067 10001068 10001069 10001070 10001072 10001073 10001074 10001075 10001076 10001077 10001078 10001079 10001084 10001085 10001086 10001087 10001088 10001089 10001090 10001091 10001092 10001093 10001096 10001098 10001099 10001100 10001101 10001102 10001104 10001105 10001107 10001108 10001109 10001110 10001111 10001112 10001113 10001114 10001116 10001117 10001120 10001121 10001125 10001128 10001129 10001130 10001132 10001135 10001136 10001137 10001138 10001139 10001140 10001141 10001142 10001143 10001144 10001145 10001149 10001150 10001152 10001153 10001157 10001158 10001159 10001160 10001161 1000116 (2) 20000026 20000061 20000062 20000068 20000078 20000079 20000086 SN10001002 SN10001003 SN10001004 SN18000002 SN18000006 SN18000013 SN18000018 SN18000024 SN19000007 SN19000017 Serial Numbers OUS: Serial Number 10000042 SN10001000 SN10001006 10001055 10001071 10001082 10001083 10001094 10001095 10001103 10001106 10001118 10001119 10001123 10001133 10001134 10001155. ***ADDED TO SCOPE 20 Nov 2024*** 1) SN18000003 SN18000017 SN18000022 SN19000005 2) Serial Number 10001147 10001115 10001156 (Germany) 10001166 10001167 10001168 10001173 10001174 10001175 10001176 10001177 10001180 10001201 10001204 10001206. REMOVED 20 Nov 2024. REF:706110 S/N: 10001055 10001071 10001082 10001083 10001094

Quantity Affected: 151 units; 138 units US; 13 units OUS

Reason for Recall

Issue 1: Mixed Images: The Radio Fluoroscopy (RF) viewer may also display a previous patient s radiography (RAD) images when starting the next patient scan while the previous patient image export is still processing. If the issue occurs, there is a potential for incorrect patient data to be displayed in the image. Issue 2: Detector Access point: Security vulnerability specific to the Wireless Portable Detector configuration items in Philips Support Connect (PSC). Due to this vulnerability it is possible, with physical access to the system and knowledge of specific settings, to modify and export data to removable media (example: USB)

Distribution

Nationwide Foreign: Australia Germany India Italy Malaysia Panama Thailand

Type: Voluntary: Firm initiated

Recall Initiated: 2023-12-15

Company

Philips North America

Cambridge, MA

Context & Analysis

This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.

This was one of 164 device recalls issued in the same week, part of 403 device-related FDA actions this month.

Philips North America has 126 FDA actions in our database, including 126 recalls.

Frequently Asked Questions

What is a Class II recall?

A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.

What should I do if I have this product?

Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Philips North America) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.

How often does Philips North America have FDA actions?

Philips North America has 126 FDA actions in our database, including 126 recalls and 0 device clearances.

Where can I find the official FDA record?

The official record is available on FDA.gov. Search for "Z-1072-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

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