Summary
The FDA issued a Class II for CombiDiagnost R90 Software Version R1.0 and R1.1 by Philips Medical Systems Gmbh, DMC. Reason: Philips has become aware of a software issue, where the kV and mA values are not locked immediately but change when the collimator shutter position is.
Details
Source
Device Recall
External ID
Z-2357-2021
Action Date
2021-09-08
Status
Ongoing
Category
device
Product Description
CombiDiagnost R90 Software Version R1.0 and R1.1
Lot/Code Info: Model 706100
Quantity Affected: 322 systems; 66 in US
Reason for Recall
Philips has become aware of a software issue, where the kV and mA values are not locked immediately but change when the collimator shutter position is changed directly after the Lock-In command. This software issue leads to an over or under exposed image.
Distribution
US Nationwide Distribution
Type: FDA Mandated
Recall Initiated: 2020-07-22
Company
Hamburg, N/A
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 126 device recalls issued in the same week, part of 403 device-related FDA actions this month.
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 Medical Systems Gmbh, DMC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Philips Medical Systems Gmbh, DMC have FDA actions?
This is the only FDA action we have on record for Philips Medical Systems Gmbh, DMC in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2357-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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