Recall record at a glance
| Official record | Z-0239-2019 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Philips Medical Systems Gmbh, DMC |
| Report date | Oct 31, 2018 |
| Recall initiation date | Sep 19, 2018 |
| Quantity | 829 units |
| Location | Hamburg, N/A, Germany |
Official product description
Philips DigitalDiagnost software 4.1.x and 4.2.x, A Stationary X-ray System Models: 712027, 712028, 712029, 712031, 712032701032, 712033, 712224, 712225, 712226, 712227, 712228.
Why the product was recalled
Stitching run on SkyPlate detector interrupted intermittently; Stitching with SkyPlate aborts after first image; System software CD contains wrong baseline
Distribution information
Worldwide distribution - US Nationwide and countries of Canada Argentina Australia Austria Bangladesh Belgium Bolivia Brazil Chile China Colombia Czech Republic Denmark Egypt Finland France French Guiana Germany Guadeloupe Hong Kong Hungary India Indonesia Iran Israel Italy Japan Jordan Korea, Republic of Kuwait Kyrgyzstan Latvia Luxembourg Maldives Martinique Mexico Netherlands New Zealand Norway Panama Peru Poland Portugal Qatar Romania Russian Federation Saudi Arabia Singapore Slovenia South Africa Spain Sweden Switzerland Taiwan Thailand Turkey United Arab Emirates United Kingdom
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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