MR 7700 systems recalled over elastography stiffness value errors
Philips North America is recalling 9 units of the MR 7700 MR system because exported MR Elastography stiffness maps may show stiffness value errors.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine."
Plain-English summary
The Philips MR 7700, product codes 782120 and 782153, covering MR systems with software versions R11.1 and R12.1, is being recalled by Philips North America.
The reason given in the enforcement record is the potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps in a viewer Picture Archiving and Communication System (PACS).
The record lists 9 units, with UDI-DI codes and serial numbers recorded in the enforcement record. Distribution was worldwide, including nationwide in the United States across the states listed in the record. The FDA has classified the action as Class II.
An incorrect stiffness value is a measurement a clinician reads. The enforcement record reports no injuries. Facilities should follow Philips' instructions.
The recalled product
- Product
- Brand Name: Broselow Product Name: Broselow Domestic Complete ALS Organizer Model/Catalog Number: 7730ALS Software Version: Not Applicable Product Description: The Broselow Tape is a length- and weight-based reference tool specifically designed for pediatric emergency care.…
- Manufacturer
- SunMed Holdings, LLC
- Category
- Medical Device — MRI
- Affected units
- 384
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by SunMed Holdings, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 4 products in this recall →Related recalls
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