Philips Digital Diagnost Software Recall for Image Marker Error
Philips is recalling Digital Diagnost Software R2.0.2 because a mirrored image marker can be mistaken for a patient side indicator.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (medical imaging software) where a marker error could lead to misinterpretation of patient side, but no injuries or illnesses have been reported.
Plain-English summary
Philips Healthcare Inc. is recalling 623 units of Digital Diagnost Software Version R2.0.2 and 2.0.2 SP1. The software is used for making X-ray exposures for diagnostics. The recall affects models 712020 and 712022 distributed worldwide, including the United States and numerous international locations.
The recall is due to a software defect where a mirrored "R in a circle" symbol is burnt into the lower right corner of the image. When the image is mirrored back inside the PACS system, the symbol appears in the lower left corner. This placement can be mistaken for a "Right patient side" marker, even though the marker may actually appear on the left patient side.
The source text does not specify specific actions for consumers or healthcare providers, nor does it report any illnesses or injuries. The recall is classified as Class II by the FDA.
The recalled product
- Product
- Philips Digital Diagnost Software Version R2.0.2 Product Usage: This system is used for making X-ray exposures for diagnostics
- Manufacturer
- Philips Healthcare Inc.
- Hazard
- Affected units
- 623
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- All Digital Diagnost systems with release 2.0.2 and 2.0.2 SP1 Models 712020
- 712022
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Philips Healthcare Inc.
See all →- ModeratePhilips Recalls Mobile Diagnostic X-Ray Systems Due to Marker Placement Error
FDA (Devices) · 2017-04-12
- HighPhilips IntellVue Info Center Patient Monitor Recall for Reboot Loop
FDA (Devices) · 2014-06-18
- ModeratePhilips Easy Upgrade DR Recalled for Potential Image Marker Misinterpretation
FDA (Devices) · 2013-09-04
- LowPhilips MobileDiagnost wDR Recalled for Non-Compliant Instructions for Use
FDA (Devices) · 2013-08-28
- ModeratePhilips IntelliVue Smart-hopping 1.4 GHz Access Point Recalled for Signal Loss
FDA (Devices) · 2013-07-31
Same hazard · mis labeling
See all →- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-10-14
- SevereBetter Bakehouse Recalls Donutful Chocolate Dipped Vanilla Cake Donuts for Undeclared Milk
FDA (Food) · 2026-10-14
- HighFreshPoint Recalls Cranberry Chicken Salad Wedges for Undeclared Egg Allergen
FDA (Food) · 2026-10-14
- HighJ K Patisserie & Bakery LLC Recalls Croissants for Undeclared Egg
FDA (Food) · 2026-10-14
- LowMindray ePM Series Patient Monitor Manuals Recalled for Alarm Clarification
FDA (Devices) · 2026-10-14
Similar recalls
- HighPhilips Digital Diagnost Software Recall for Image Marker Error
FDA (Devices) · 2012-06-27
- ModeratePhilips DigitalDiagnost X-Ray System Recalled for Image Rotation Errors
FDA (Devices) · 2013-03-06
- ModeratePhilips Digital Diagnost Radiographic System Recalled for Image Rotation Errors
FDA (Devices) · 2013-03-13
- ModeratePhilips DigitalDiagnost Software Recall for X-ray System Stitching Defects
FDA (Devices) · 2018-10-31
- ModeratePhilips Easy Upgrade DR Recalled for Potential Image Marker Misinterpretation
FDA (Devices) · 2013-09-04
- ModeratePhilips Recalls Mobile Diagnostic X-Ray Systems Due to Marker Placement Error
FDA (Devices) · 2017-04-12