DigitalDiagnost 4 Flex / Value. radiography and fluoroscopy system
Summary
The FDA issued a Class II for DigitalDiagnost 4 Flex / Value. radiography and fluoroscopy system by Philips Medical Systems DMC GmbH. Reason: Following a system restart where the Table Height 2 (TH2) is the default setting and then switched to Wallstand VS2, operators will see an incorrect o.
Details
Source
Device Recall
External ID
Z-1327-2022
Action Date
2022-07-20
Status
Ongoing
Category
device
Product Description
DigitalDiagnost 4 Flex / Value. radiography and fluoroscopy system
Lot/Code Info: Model 712032 Serial Numbers - 10001088 10001097 10001104 10001112 19000317 10001095 10001102 10001105
Quantity Affected: 140 systems in total, (Updated 1/30/2023).
Reason for Recall
Following a system restart where the Table Height 2 (TH2) is the default setting and then switched to Wallstand VS2, operators will see an incorrect orientation of image on the first examination due to an issue in the firmware of the Wallstand VS2 board. The system will rotate the amplimat field selection by 90 degrees. The wrong amplimat field selection may cause an incorrect dose of radiation to occur. Additionally, the anatomic position markers may become mispositioned and could potentially be associated with the opposite side of the anatomy. (Updated 1/30/23) Expansion of the root cause to include incorrect amplimat field selection by 90 degrees following the first exposure using Wallstand VS2 and a subsequent system restart. Previously, this issue only occurred following a system restart where the Table Height 2 (TH2) is the default setting.
Distribution
US Nationwide Distribution
Type: FDA Mandated
Recall Initiated: 2021-05-19
Company
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 143 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Philips Medical Systems DMC GmbH has 15 FDA actions in our database, including 11 recalls and 4 clearances.
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 DMC GmbH) 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 DMC GmbH have FDA actions?
Philips Medical Systems DMC GmbH has 15 FDA actions in our database, including 11 recalls and 4 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1327-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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