Philips ProxiDiagnost N90 radiography systems recalled due to cable damage
Philips is recalling certain ProxiDiagnost N90 radiography systems due to a cable under the table that may break. A broken cable could prevent users from tilting the table or engaging braking.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This Class II FDA medical device recall involves a cable that can break and cause loss of critical table-tilting and braking functions. Although no injuries have been reported, the potential for harm during clinical procedures fits the rubric criterion of risk-of-harm products where injury has not yet been reported.
Plain-English summary
Philips North America LLC is recalling ProxiDiagnost N90 1.0 (Model 706100) and ProxiDiagnost N90 1.1 (Model 706110) radiography and fluoroscopy systems. A total of 234 units have been affected: 195 in the United States, including Puerto Rico, and 39 in other countries including Australia, Chile, China, Germany, India, Italy, Malaysia, Netherlands, Panama, Spain, and Thailand.
The ProxiDiagnost N90 table contains a cable located under the tabletop, covered by a plastic sleeve. The plastic sleeve can crack and damage the underlying cable.
If the tabletop cable breaks, users may not be able to perform table tilting movements or activate table braking. This could impact the equipment's functionality during clinical procedures.
The FDA has classified this as a Class II recall. For information about affected units and remediation options, customers should contact Philips North America LLC or refer to the FDA recall notice.
The recalled product
- Product
- Philips ProxiDiagnost N90 1.0 (Model 706100) and ProxiDiagnost N90 1.1 (Model 706110)- A multi-functional general radiography and fluoroscopy (R/F) system
- Manufacturer
- Philips North America Llc
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI: (01)00884838085619(21) ProxiDiagnost N90 1.0 (706100)
Distribution
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