Recall record at a glance
| Official record | Z-2175-2017 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Philips Electronics North America Corporation |
| Report date | Jun 7, 2017 |
| Recall initiation date | May 4, 2017 |
| Quantity | 9120 devices |
| Location | Andover, MA, United States |
Official product description
NMT Patient Cable (989803174581) in use with lntelliVue NMT Module (Part# 865383)
Why the product was recalled
Manufacturing defect may cause localized heating, which may result in localized skin burn.
Distribution information
US: AK AZ CA CO FL HI IA IL IN KY MA MD MI MN MO MS NC NE NH NJ NM NV NY OH OR PA TX VA WA WI WV OUS: Algeria Argentina Australia Austria Bahrain Belarus Belgium Bolivia Brazil Canada Chile China Colombia Costa Rica Denmark Dominican Rep Egypt Finland France Germany Hong Kong Hungary Iceland India Indonesia Ireland Israel Italy Japan Latvia Lebanon Libya Lithuania Luxembourg Malaysia Mexico Mongolia Netherlands New Zealand Norway Oman Pakistan Peru Philippines Poland Portugal Qatar Romania Russia Russian Fed. Saudi Arabia Singapore Slovenia South Africa South Korea Spain Sweden Switzerland Taiwan Thailand Tunisia Turkey Ukraine United Kingdom Utd.Arab.Emir.
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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