Class II Recall

Spectral CT 7500: Software Version 5.0, Model 728333 and Spectral CT 7500 China: Software Version 5.0, Model 728340.

Summary

The FDA issued a Class II for Spectral CT 7500: Software Version 5.0, Model 728333 and Spectral CT 7500 China: by PHILIPS MEDICAL SYSTEMS. Reason: A software issue that can incorrectly label all captured images that may lead to misdiagnosis and subsequent incorrect treatment..

Details

Source

Device Recall

External ID

Z-1055-2024

Action Date

2024-02-14

Status

Ongoing

Product Description

Spectral CT 7500: Software Version 5.0, Model 728333 and Spectral CT 7500 China: Software Version 5.0, Model 728340.

Lot/Code Info: UDI-DI: 00884838101111, Model 728333, serial numbers: 10197, 10182, 10175, 10192, 10179, 10196, 10180, 10188, 10190, 10181, 10183, 10178, 10186, 10185, 10199, 10184, 10198, 10193, 10187, 10189, 10195, 10191, 10194, 10018, 10023, 10027, 10062, 10072, 10078, 10079, 10080, 10084, 10088, 10101, 10104, 10112, 10117, 10113, 10116, 10032, 10049, 10133, 10140, 10152, 10153, 10166, 10170, 10171, 10173, 10172, 10174, 10016, 10015, 10017, 10019, 10022, 10021, 10020, 10025, 10024, 10033, 10031, 10034, 10035, 10036, 10038, 10039, 10040, 10041, 10043, 10042, 10014, 10044, 10046, 10048, 10045, 10047, 10051, 10050, 10053, 10055, 10052, 10056, 10058, 10057, 10059, 10060, 10061, 10065, 10066, 10068, 10067, 10070, 10071, 10063, 10069, 10074, 10075, 10077, 10076, 10081, 10082, 10087, 10089, 10085, 10086, 10091, 10092, 10094, 10093, 10095, 10096, 10090, 10099, 10098, 10102, 10100, 10103, 10097, 10105, 10106, 10107, 10108, 10109, 396001, 396003, 10110, 10111, 10114, 10115, 10122, 10118, 10120, 10121, 10123, 10119, 10124, 10125, 10126, 10127, 10129, 10128, 10131, 10130, 10132, 10135, 10136, 10134, 10137, 10139, 10138, 10142, 10141, 10143, 10144, 10145, 10146, 10147, 10149, 10150, 10151, 10155, 10156, 10159, 10148, 10160, 10161, 10162, 10158, 10164, 10163, 10165, 10167, 10168, 10169, 10013, 10177, 10176. Model: 728340, serial numbers: 397022, 397023, 397020, 397024, 397021, 397025, 397027, 397031, 397026, 397033, 397032, 397030, 397028, 397029, 397015, 397016, 397004, 397007, 397005, 397002, 397006, 397008, 397010, 397003, 397011, 397013, 397009, 397012, 397014, 397017, 397019, 397018. .

Quantity Affected: US: 33, OUS 177

Reason for Recall

A software issue that can incorrectly label all captured images that may lead to misdiagnosis and subsequent incorrect treatment.

Distribution

Worldwide - US Nationwide distribution in the states of AR, AZ, GA, HI, IN, KY, MA, MD, MN, NY, OH, PA, TX & WV; the countries of Australia, Austria, Belgium, China, Czech Republic, Denmark, Germany, Israel, Italy, Japan, Macao, Malaysia, Netherlands, Norway, Palestine, Panama, Portugal, Singapore, South Korea, Spain, Switzerland, Taiwan, Thailand & United Kingdom.

Type: Voluntary: Firm initiated

Recall Initiated: 2023-12-13

Company

PHILIPS MEDICAL SYSTEMS

Cambridge, MA

Context & Analysis

This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.

This was one of 274 device recalls issued in the same week, part of 403 device-related FDA actions this month.

PHILIPS MEDICAL SYSTEMS has 10 FDA actions in our database, including 8 recalls and 2 clearances.

Frequently Asked Questions

What is a Class II recall?

A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.

What should I do if I have this product?

Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (PHILIPS MEDICAL SYSTEMS) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.

How often does PHILIPS MEDICAL SYSTEMS have FDA actions?

PHILIPS MEDICAL SYSTEMS has 10 FDA actions in our database, including 8 recalls and 2 device clearances.

Where can I find the official FDA record?

The official record is available on FDA.gov. Search for "Z-1055-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

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