Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported August 28, 2013
Philips Healthcare MobileDiagnostwDR system. Mobile Digital radiography X-Ray System Product Usage: MobileDiagnost wDR is a mobile digital radiography X-Ray System. It is intended for use by a qualified/trained doctor or technologist on both adult and pediatric patients for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with patient sitting, standing, or lying in the prone or supine posit
The Instructions for Use (IFU) for the MobileDiagnost wDR fails to comply with a Federal standard. The IFU does not provide tolerance levels for several generator values as requir…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Philips Healthcare Inc. recalled Philips Healthcare MobileDiagnostwDR system. Mobile Digital radiography X-Ray System … - a moderate-severity action.
Philips Healthcare MobileDiagnostwDR system. Mobile Digital radiography X-Ray System … was recalled by Philips Healthcare Inc. in August 28, 2013. Reason: The Instructions for Use (IFU) for the MobileDiagnost wDR fails to comply with a Federal standard. The IFU do…. Check the official notice for the remedy. Verify recall #Z-1964-2013 with the FDA Devices before acting.
The recall
Philips Healthcare Inc. issued this moderate-severity FDA Devices recall-The Instructions for Use (IFU) for the MobileDiagnost wDR fails to comply with a Federal standard. The IFU do….
- Moderate
- severity level
- Class II
- classification
- August 28, 2013
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1964-2013 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1964-2013) was formally reported on August 28, 2013, with the manufacturer initiating the action on June 11, 2013. 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 240 systems US -- 1 system within Puerto Rico.
The documented reason for this recall is: The Instructions for Use (IFU) for the MobileDiagnost wDR fails to comply with a Federal standard. The IFU does not provide tolerance levels for several generator values as required by 1020.30(h)(3). Distribution data in the federal record shows the product reached: US Nationwide Distribution including Puerto Rico. 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.
Medical Devices recalls over time
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.
Affected scope
240 systems US -- 1 system within Puerto Rico
Related Recalls
6
3 from same agency
Product description
Philips Healthcare MobileDiagnostwDR system. Mobile Digital radiography X-Ray System Product Usage: MobileDiagnost wDR is a mobile digital radiography X-Ray System. It is intended for use by a qualified/trained doctor or technologist on both adult and pediatric patients for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with patient sitting, standing, or lying in the prone or supine positions. Not intended for mammography.
Reason for recall
The Instructions for Use (IFU) for the MobileDiagnost wDR fails to comply with a Federal standard. The IFU does not provide tolerance levels for several generator values as required by 1020.30(h)(3).
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1964-2013 |
| Date reported | August 28, 2013 |
| Date initiated | June 11, 2013 |
| Recalling firm | Philips Healthcare Inc. |
| Firm location | Andover, MA |
| Affected scope | 240 systems US -- 1 system within Puerto Rico |
| Distribution | US Nationwide Distribution including Puerto Rico |
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.
- Check the recall number (Z-1964-2013) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
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.
Frequently Asked Questions
What product was recalled? ▼
Philips Healthcare MobileDiagnostwDR system. Mobile Digital radiography X-Ray System Product Usage: MobileDiagnost wDR is a mobile digital radiography X-Ray System. It is intended for use by a qualified/trained doctor or technologist on both adult and pediatric patients for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with patient sitting, standing, or lying in the prone or supine positions. Not intended for mammography.. Recalled by Philips Healthcare Inc.. Units affected: 240 systems US -- 1 system within Puerto Rico.
Why was this product recalled? ▼
The Instructions for Use (IFU) for the MobileDiagnost wDR fails to comply with a Federal standard. The IFU does not provide tolerance levels for several generator values as required by 1020.30(h)(3).
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 28, 2013. Severity: Moderate. Recall number: Z-1964-2013.
Where was the recalled product distributed? ▼
Distribution: US Nationwide Distribution including Puerto Rico.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1964-2013) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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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 August 28, 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.