Severity
Moderate
FDA Devices recall · Reported March 13, 2013
When the operator for a wall stand view selects an "image rotation" different from default, or such image rotation is preset in the examination database, then the resulting image…
Philips Healthcare Inc. recalled Philips Digital Diagnost Stationary radiographic system - a moderate-severity action.
Philips Digital Diagnost Stationary radiographic system was recalled by Philips Healthcare Inc. in March 13, 2013. Reason: When the operator for a wall stand view selects an "image rotation" different from default, or such image rot…. Check the official notice for the remedy. Verify recall #Z-0900-2013 with the FDA Devices before acting.
The recall
Philips Healthcare Inc. issued this moderate-severity FDA Devices recall-When the operator for a wall stand view selects an "image rotation" different from default, or such image rot….
Sourced from official FDA Devices enforcement records. Verify recall #Z-0900-2013 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
This FDA Devices action (record #Z-0900-2013) was formally reported on March 13, 2013, with the manufacturer initiating the action on October 30, 2012. It is classified under Moderate severity (Class II), with a current status of Terminated. Philips Healthcare Inc. is listed as the recalling firm, operating out of Andover, MA. Federal records list the affected scope as 360.
The documented reason for this recall is: When the operator for a wall stand view selects an "image rotation" different from default, or such image rotation is preset in the examination database, then the resulting image may be rotated in the wrong direction. … Distribution data in the federal record shows the product reached: Worldwide Distribution - USA (nationwide) and Internationally to Argentina, Australia, Austria, Canada, Chile, Czech republic, Estonia,France, Germany, Hungary, Inida, Ireland, Italy, Japan, Libyan Arab Jamahari, Mexico…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Severity
Moderate
Affected scope
360
Related Recalls
6
3 from same agency
Philips Digital Diagnost Stationary radiographic system
When the operator for a wall stand view selects an "image rotation" different from default, or such image rotation is preset in the examination database, then the resulting image may be rotated in the wrong direction. When the operator manually rotates the image back, electronic side markers (if programmed) are rotated also and as a result may be placed in a wrong position inside the image.
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0900-2013 |
| Date reported | March 13, 2013 |
| Date initiated | October 30, 2012 |
| Recalling firm | Philips Healthcare Inc. |
| Firm location | Andover, MA |
| Affected scope | 360 |
| Distribution | Worldwide Distribution - USA (nationwide) and Internationally to Argentina, Australia, Austria, Canada, Chile, Czech republic, Estonia,France, Germany, Hungary, Inida, Ireland, Italy, Japan, Libyan Arab Jamahari, Mexico, Netherlands, New Z… |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported March 13, 2013. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.